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Sr Quality Engineer jobs at Teva in United States, Salt Lake City

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United States
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Salt Lake City
7 jobs found
18.11.2025
T

Teva Quality Analyst II United States, Utah, Salt Lake City

Limitless High-tech career opportunities - Expoint
Responsible for providing a thorough and timely review and approval of cGMP documents and processes such as those related to deviations, investigations, equipment and facilities Maintenance and calibration, protocols and...
Description:

This role provides Quality Assurance support to Manufacturing, Supply Chain, and Quality Control Laboratories. Responsibilities include reviewing and approving QA methods, procedures, protocols, investigation documents, and change control documents. The position uses trend and investigational data to improve processes and reduce failures, while representing the quality department on cross-functional teams.


ESSENTIAL AREAS OF RESPONSIBILITY

• Responsible for providing a thorough and timely review and approval of cGMP documents and processes such as those related to deviations, investigations, equipment and facilities Maintenance and calibration, protocols and reports, and facility controls, instruments and procedures.
• Responsible for working with operating departments to facilitate process improvements and lean concepts.
• Responsible for participating in cross functional improvement and process monitoring teams to mitigate unfavorable trends.
• Responsible for providing first response and ongoing QA presence for quality and compliance issues on the manufacturing floor and as needed in the laboratories.
• Responsible for evaluating reports of deviations from defined processes and working with QA to determine if incidents should be escalated to an event investigation.
• Responsible for conducting comprehensive investigations of complex and/or challenging events as assigned.
• Responsible for completing all actions necessary in system to document investigations, identify root causes, create and assign appropriate CAPA’s and gain approval and closure of an event.
• Responsible for investigating critical events, supporting other quality team members in the analysis and documentation.
• Responsible for compiling and maintaining metrics and tracking logs for site’s quality KPI’s or other functions.
• Responsible for supporting activities within electronic systems as needed, such as LIMS, TrackWise, EAM
• Responsible for serving as QA backup as final review/release of production batch records.
• Responsible for completing training requirements and maintaining compliance with all assignments.
• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP’s) and Batch Record instructions.
• Responsible for performing additional related duties as assigned.


Your experience and qualifications

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.

Education/Certification/Experience:
• Requires a Bachelor’s Degree or equivalent with a minimum of three years relevant progressive QA experience in the pharmaceutical or a related industry.
• Prefer degree in Science or Engineering.
• Requires experience with and an in-depth knowledge of cGMP and other applicable industry regulatory requirements as they relate to the production of pharmaceutical products and associated quality systems.
• Requires experience with the handling of deviations, investigations and CAPA’s.
• Experience with Manufacturing/Quality systems such as Trackwise, Labware, Veeva, Learning Management Systems and statistical software preferred.
• Experience with laboratory related investigations/inquiries preferred.
• ASQ/CQE/CQA Certification preferred.Skills/Knowledge/Abilities:
• Detail oriented with ability to analyze information and create corresponding performance metrics.
• Computer proficiency with comprehensive working knowledge of MS Office products and computer relational databases.
• Ability to demonstrate sound judgment and decision making.
• Ability to build and maintain collaborative relationships between teams, departments and business units.
• Communicate effectively with excellent written and oral communication skills.
• Interact positively and collaborate with co-workers, management and external partners.
• Manage conflict and negotiate resolution.
• Self-directed with ability to organize and prioritize work.

Problem Solving:
• Proactively works on problems of a moderate to complex scope where evaluation of contributing factors requires the analysis of situations or data and an in-depth knowledge and evaluation of various known and unknown factors.
• Seeks out all resources when selecting methods and techniques for obtaining results.
• Acts independently and proactively to recommend and administer methods and procedures for problem resolution.

TRAVEL REQUIREMENTS
• N/A

PHYSICAL REQUIREMENTS:
Frequent:
• Using fingers to perform activities such as picking, pinching or typing.
• Repetitive Motions – frequent motions of the wrists, hands and/or fingers.
• Sitting for extended periods of time.

Occasional:
• Standing for extended periods of time at work station or equipment.
• Walking to move short distances quickly and frequently.
• Grasping – applying pressure to an object with the fingers and palm
• Lifting – raising objects from lower to upper and/or moving objects horizontally – up to 25 lbs.

Visual Acuity:
• Perform activities such as computer work, preparing and analyzing data, extensive reading, visual inspection involving small defects, small parts and/or operation of machines (including inspection), using measurement devices and/or assembly or fabrication of parts at a distance close to the eyes.

WORKING ENVIRONMENT:
• Occasional exposure to moderate to loud noise levels.
• Occasional exposure to moving mechanical parts or equipment.
• Occasional exposure to fumes, odors, dusts, mists, gasses or vibrations.
• May be required to wear personal protective equipment (PPE) as needed when in production areas (i.e. safety glasses, respirator, hearing protection, gloves, etc.).

We offer a competitive benefits package, including:
• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

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18.11.2025
T

Teva Quality Specialist II - First Shift Mon -Fri am pm United States, Utah, Salt Lake City

Limitless High-tech career opportunities - Expoint
Strategic Leadership: Develop and refine global commercial strategies for early-stage immunology assets aligned with Teva’s long-term portfolio vision. Early Asset Development: Shape Target Product Profiles (TPPs), indication prioritization, and clinical...
Description:

This position can be based in the US (Parsippany), the Netherlands (Haarlem) or the UK. (In the UK, it can be based remotely.)

TRAVEL REQUIREMENTS Approximately up to 20% travel to support key meetings and cross-functional planning.

How you’ll spend your day
  • Strategic Leadership: Develop and refine global commercial strategies for early-stage immunology assets aligned with Teva’s long-term portfolio vision.
  • Early Asset Development: Shape Target Product Profiles (TPPs), indication prioritization, and clinical endpoints to optimize future commercial success.
  • Business Development Support: Partner with BD teams to evaluate external opportunities, lead commercial due diligence, and inform licensing or acquisition decisions.
  • Market & Competitive Insight: Conduct early market assessments, unmet need analyses, and scenario planning to identify opportunities and risks.
  • Cross-Functional Collaboration: Ensure early commercial input informs R&D, Medical, Market Access, and Regulatory strategies.
  • Forecasting & Planning: Build long-range forecasts and strategic models to guide investment and governance decisions.
  • External Engagement: Partner with KOLs, advocacy groups, and external experts to validate assumptions and shape early strategic direction.
Your experience and qualifications
  • Bachelor’s degree required; Master’s or advanced degree preferred.
  • A minimum of 15 years in the pharmaceutical or life sciences industry, with a minimum of 10 years in commercial or marketing leadership roles.
  • Proven experience with pipeline strategy, early asset development, or business development.
  • Strong understanding of immunology (experience across multiple therapeutic areas a plus).
  • Demonstrated ability to translate science into strategy and drive cross-functional alignment.
  • Strategic thinker with exceptional analytical, communication, and leadership skills.
  • Experience in Insights or Analytics is advantageous.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

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18.11.2025
T

Teva Sr Quality Engineer United States, Utah, Salt Lake City

Limitless High-tech career opportunities - Expoint
Responsible for providing a thorough and timely review/approval or author/execution of cGMP documents and processes such as those related to deviations, investigations, equipment and facilities maintenance and calibration, protocols and...
Description:

ESSENTIAL AREAS OF RESPONSIBILITY

• Responsible for providing a thorough and timely review/approval or author/execution of cGMP documents and processes such as those related to deviations, investigations, equipment and facilities maintenance and calibration, protocols and reports, and facility controls, instruments, and procedures.
• Responsible for working with operating departments to facilitate process improvements and lean concepts.
• Responsible for leading cross functional improvement and process monitoring teams to mitigate unfavorable trends.
• Responsible for providing first response and ongoing QA presence for quality and compliance issues on the manufacturing floor and as needed in the laboratories.
• Responsible for evaluating reports of deviation from defined processes and working with QA to determine if incidents should be escalated to an event investigation.
• Responsible for conducting comprehensive investigations of critical, complex and/or challenging events as assigned.
• Responsible for serving as QA lead on research and development products and related document reviews/approvals – including change control items, protocols, batch records and deviations as applicable and product disposition.
• Responsible for working with the laboratory to investigate OOT and OOS events, providing feedback and manufacturing information.
• Responsible for compiling and maintaining metrics and tracking logs for site’s quality KPI’s or other functions.
• Responsible for supporting internal/external, scheduled and unscheduled audits of operational areas.
• Responsible for supporting activities within electronic systems as needed, such as LIMS, TrackWise, EAM.
• Responsible for serving as QA backup for final review/release of production batch records, managing the site change control system and for validation/qualification protocols and related activities.
• Responsible for completing training requirements and maintaining compliance with all assignments.
• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP’s) and Batch Record instructions.
• Responsible for performing additional related duties as assigned.


Your experience and qualifications

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.

Education/Certification/Experience:
• Requires a Bachelor’s Degree or equivalent with a minimum of seven years relevant progressive QA experience in the pharmaceutical or a related industry.
• Prefer degree in Science or Engineering.
• Preferred experience in a solid dose manufacturing environment.
• Requires experience with and an in-depth knowledge of cGMP and other applicable industry regulatory requirements as they relate to the production of pharmaceutical products and associated quality systems.
• Requires experience with the handling of deviations, investigations and CAPA’s.
• Experience with managing partner relationships preferred.
• Experience with Manufacturing/Quality systems such as Trackwise, Labware, Veeva, Learning Management Systems and statistical software preferred.
• Experience with laboratory related investigations/inquiries preferred.
• ASQ/CQE/CQA Certification preferred.Skills/Knowledge/Abilities:
• Detail oriented with ability to analyze information and create corresponding performance metrics.
• Computer proficiency with comprehensive working knowledge of MS Office products and computer relational databases.
• Ability to demonstrate sound judgment and decision making.
• Ability to build and maintain collaborative relationships between teams, departments and business units.
• Motivate, influence and lead others with and/or without direct supervisory authority.
• Communicate effectively with excellent written and oral communication skills.
• Interact positively and collaborate with co-workers, management and external partners.
• Manage conflict and negotiate resolution.
• Self-directed with ability to organize and prioritize work.
• Project management and advanced presentation skills preferred.

Problem Solving:
• Proactively works on problems of a moderate to complex scope where evaluation of contributing factors requires the analysis of situations or data and an in-depth knowledge and evaluation of various known and unknown factors.
• Seeks out all resources when selecting methods and techniques for obtaining results.
• Acts independently and proactively to recommend and administer methods and procedures for problem resolution.

TRAVEL REQUIREMENTS
• N/A


PHYSICAL REQUIREMENTS:
Frequent:
• Using fingers to perform activities such as picking, pinching or typing.
• Repetitive Motions – frequent motions of the wrists, hands and/or fingers.
• Sitting for extended periods of time.

Occasional:
• Standing for extended periods of time at work station or equipment.
• Walking to move short distances quickly and frequently.
• Grasping – applying pressure to an object with the fingers and palm
• Lifting – raising objects from lower to upper and/or moving objects horizontally – up to 25 lbs.

Visual Acuity:
• Perform activities such as computer work, preparing and analyzing data, extensive reading, visual inspection involving small defects, small parts and/or operation of machines (including inspection), using measurement devices and/or assembly or fabrication of parts at a distance close to the eyes.

WORKING ENVIRONMENT:
• Occasional exposure to moderate to loud noise levels.
• Occasional exposure to moving mechanical parts or equipment.
• Occasional exposure to fumes, odors, dusts, mists, gasses or vibrations.
• May be required to wear personal protective equipment (PPE) as needed when in production areas (i.e. safety glasses, respirator, hearing protection, gloves, etc.).

We offer a competitive benefits package, including:
• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

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08.10.2025
T

Teva Sr Dir Plnt/Ctry Sup Chain Lead III United States, Utah, Salt Lake City

Limitless High-tech career opportunities - Expoint
Bachelor’s degree required; advanced degree preferred. Minimum 10 years of experience in pharmaceutical manufacturing, supply chain, or materials management. Proven experience in generic pharma operations and SAP/APO systems. Strong understanding...
Description:
How you’ll spend your day

· Lead site-wide production and materials planning, inventory control, and product project management.

· Drive strategic planning using SAP/APO and other ERP tools to optimize capacity and resource allocation.

· Collaborate with Market Planners and external suppliers to ensure supply continuity and support new product launches.

· Champion the Sales & Operations Planning (S&OP) process, presenting capacity status and resolving bottlenecks.

· Build and mentor a high-performing team, fostering talent development and succession planning.

· Partner cross-functionally with R&D, Commercial, and Manufacturing to align supply chain strategy with business goals.

Your experience and qualifications

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.

  • Bachelor’s degree required; advanced degree preferred.
  • Minimum 10 years of experience in pharmaceutical manufacturing, supply chain, or materials management.
  • Proven experience in generic pharma operations and SAP/APO systems.
  • Strong understanding of cGMP and regulatory requirements.
  • APICS certification preferred.
  • Exceptional leadership, communication, and cross-functional collaboration skills.

Skills/Knowledge/Abilities:

  • Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), ERP system such as SAP or Oracle and manufacturing/quality systems such as Trackwise and Qdocs.
  • Self-directed with ability to organize and prioritize work.
  • Ability to motivate, influence and lead others with and/or without direct supervisory authority.
  • Ability to positively manage conflict, provide difficult feedback and negotiate resolution.
  • Ability to build and maintain collaborative relationships between teams, departments, business units and external partners.
  • Ability to demonstrate sound judgment and decision making.
  • Ability to identify the developmental needs of others and provide coaching, mentoring and encouragement to help others improve their knowledge or skills.
  • Ability to communicate effectively with excellent written and oral communication skills.
  • Project management and advanced presentation skills preferred.

TRAVEL REQUIREMENTS: Up to 20%

We offer a competitive benefits package, including:

Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.

Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.


The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

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21.07.2025
T

Teva Senior Quality Auditor - SLC East Mon- Fri 2pm 1030pm United States, Utah, Salt Lake City

Limitless High-tech career opportunities - Expoint
Carries out lead responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws. Assists in the training of new auditors in job duties according to Standard...
Description:

Under minimum supervision, ensures compliance to cGMP regulations in manufacturing area including all documentation complying with the Company's Standard Operating Procedures (SOP's), governmental regulations and other requirements where applicable. Facilitates communication between departments to ensure a smooth flow of materials and release. Perform batch record review of intermediate and finished materials. Perform release of intermediate materials.

How you’ll spend your day

All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. This role requires knowledge and experience in own discipline; still acquiring higher level knowledge and skills. Build knowledge of the organization, processes, and customers. Solve a range of straightforward problems. Analyzes possible solutions using standard procedures. Receives low to moderate level of guidance and direction. Any non-essential functions are assumed to be included in other related duties or assignments.

  • Carries out lead responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws.
  • Assists in the training of new auditors in job duties according to Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs) and Company training procedures.
  • Perform review of intermediate and finished material batch records.
  • Interface with manufacturing, warehouse, and QC materials management to ensure timely and accurate shipment of materials and products.
  • Audit data from Quality Control, vendor's certificate of analysis, and other related documentation of products and materials.
  • Prepare, revise and verify SOP, Sampling Plans, MPRs, Swab Data, and BMS system data.
  • Maintain Quality Assurance documentation files, databases, and logs.
  • Assist in preparing budgets and reviews.
  • Conduct final audit of Laboratory Service Reports for in-process and finished product reports, assuring compliance with cGMPs, current Good Laboratory Procedures (cGLPs), test methods and SOPs and prepare documentation for release.
  • Conduct audits of other documents as directed by the Supervisor and prepare these documents for release, assuring compliance with cGMPs and SOPs.
  • Interface with other department's personnel to complete job duties.
  • Participates in and provides training programs for the development of successful working understanding of materials presented and become more proficient in assigned duties and tasks.
  • Provides support, direction, and coaching to team members in the areas of training, problem resolution, planning, and work assignment delegation.
  • Ensures project deadlines and performance standards are established and met.
  • Ensures compliance with all company policies and procedures, including safety rules and regulations.
Your experience and qualifications

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.

Education/Certification/Experience:

  • Bachelor's Degree in Science or related field from an accredited college or university, and three (3) years pharmaceutical quality assurance auditing experience. An equivalent combination of education and experience may be substituted.

Skills:

  • Observing and identifying problems, assisting in resolution to support Company goals.
  • Reading, interpreting records, reports, business, personal and scientific computer data, certificates of analysis and conformance and other applicable data sources
  • Responding to inquiries from management, employees and regulatory agencies under direction of management.
  • Communicating clearly and concisely, both orally and in writing.
  • Operating scientific, business and personal computers.
  • Applying Federal, state and local policies, procedures and regulations.
  • Establishing and maintaining cooperative working relationships with others.

Knowledge/Abilities:

  • Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements.
  • Advanced principles of auditing.
  • AQL sampling and inspection principles and techniques.
  • Principles of mathematical and statistical computation and analysis.
  • Business, scientific and personal computer hardware and software applications.
  • Pharmaceutical principles, practices and their applications.
  • Leadership and training methods and techniques.

TRAVEL REQUIREMENTS : N/A

We offer a competitive benefits package, including:

Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.

Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.


The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

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20.07.2025
T

Teva Senior Quality Engineer United States, Utah, Salt Lake City

Limitless High-tech career opportunities - Expoint
Develop US labeling documents to align with company goals and submission requirements for assigned ANDAs and/or 505(b)(2)s, if required, and ensure labeling meets all legal and regulatory requirements. This includes...
Description:

The RA Associate II is responsible for preparing and revising high-quality US Gx labeling documents submitted under an ANDA and/or 505(b)(2), as required. This role ensures compliance with federal regulations, guidance documents, and internal procedures while meeting deadlines aligned with company objectives.

The candidate must demonstrate the ability to work with minimal supervision and possess a thorough understanding of US FDA labeling regulations and guidance documents, applying this knowledge effectively across all work output. Additionally, they will be responsible for creating compliant Structured Product Labeling (SPL) files, ensuring complete drug listing information, and adhering to compliance requirements for importation, bulk listings, and related processes.

How you’ll spend your day
  • Develop US labeling documents to align with company goals and submission requirements for assigned ANDAs and/or 505(b)(2)s, if required, and ensure labeling meets all legal and regulatory requirements. This includes QC, proofing, editing, and formatting of documents, and coordinating the review and approval of final submission documents
  • Develop US labeling documents needed for early development projects requiring a human factor or comparative analysis study and ensure established labeling meets all legal and regulatory requirements. This includes QC, proofing, editing, and formatting of documents, and coordinating the review and approval of final submission documents with all relevant departments
  • Some experience in developing labeling content that requires carve-outs due to protected language associated with patents/exclusivities
  • Establish and maintain SPL for assigned projects. Ensure product data elements align with the required drug listing regulations and established SPL is submitted through FDA’s Electronic Submission Gateway
  • Prepare and electronically compile full responses to the FDA via the appropriate filing mode. This includes, but is not limited to, the development of side-by-side comparisons, SPL, and other required submission materials, as necessary
  • Perform quality reviews of labeling and submission documents by proofreading established files for content accuracy, either manually or by utilizing the electronic proofreading tool TVT
  • Work closely with external departments, including CMC and the Device team, to align with internal product/device strategy and process
  • Work closely with Regulatory Operations, as well as in Teva’s publishing software, to ensure assigned projects are submitted on time following the eCTD requirements related to labeling
  • Support products falling under Business Development deals, if required, from a labeling/artwork and drug listing perspective
  • Attend assigned project meetings to ensure labeling timelines are met
  • Maintain an accurate project tracker of all assigned projects with identified due date priorities and timelines of initial assignment, initiation, and completion of projects
  • Maintain knowledge of US regulations, guidelines, and standard operating procedures applicable to US Gx labeling
  • Work in a team environment with minimal supervision
  • Perform all other job-related duties as required by management and dictated by process changes
Your experience and qualifications
  • Bachelor's in pharmacy/master's in science & Life sciences - 4-5 Years in the Pharmaceutical Industry
  • Master's in pharmacy - 3-4 Years in the Pharmaceutical Industry
  • Proven experience in regulatory affairs within the pharmaceutical, biotechnology, or medical device industry
  • Be able to multi-task in a fast-paced work environment
  • Have exemplary oral and written communication skills
  • Be organized with keen attention to detail
  • Have the ability to work independently as well as in a team environment with minimal supervision
  • Have knowledge of US FDA regulations and guidance related to US Gx labeling
  • Have knowledge of US FDA regulations and guidance related to US drug listing
  • Have knowledge of US FDA eCTD submission standards and experience in applying these requirements to routine labeling submissions to the FDA
  • PC, Microsoft Office Suite with a proficiency in Microsoft Word and Microsoft Excel
  • Adobe Acrobat Professional is a must
  • Familiarity with TVT preferred
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28.06.2025
T

Teva Quality Specialist II - First Shift Mon -Fri am pm United States, Utah, Salt Lake City

Limitless High-tech career opportunities - Expoint
Responsible for receipt and sampling of all raw materials, other chemicals and supplies. Responsible for maintaining and moving sample quantities in electronic system. Responsible for ensuring that materials are staged...
Description:

This position is responsible for the execution of the sampling function in the warehouse. Other warehouse activities including shipping, receiving, material staging, inventory maintenance and record keeping in compliance with all regulatory requirements and company policies and procedures is also required.

Essential Ares of Responsibility:

All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.

  • Responsible for receipt and sampling of all raw materials, other chemicals and supplies.
  • Responsible for maintaining and moving sample quantities in electronic system.
  • Responsible for ensuring that materials are staged properly for production areas.
  • Responsible for loading and unloading trucks and other vehicles delivering or picking up controlled and non-controlled substances from the premises.
  • Responsible for completing documents required in Production, QC and R&D, and updates to all manual and automated records as required.
  • Responsible for granting access of authorized individuals to controlled substance storage areas.
  • Responsible for training new employees on sampling processes and procedures.
  • Responsible for ensuring that the required sampling workflow is met to eliminate downtime.
  • Responsible for assisting in additional warehouse activities such as shipping, receiving, staging and inventory maintenance as needed.
  • Responsible for completing training requirements and maintaining compliance with all assignments.
  • Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP’s) and Batch Record instructions.
  • Responsible for performing additional related duties as assigned.
Your experience and qualifications

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.

Education/Certification/Experience:

  • Requires High School Diploma or equivalent
  • Minimum 1 year warehouse or related experience in a manufacturing environment within pharmaceutical, nutraceutical or food processing industries. Prefer 3 years related experience
  • Prefer forklift experience/certification

Skills/Knowledge/Abilities:

  • Basic computer skills with working knowledge of MS Office products (additional experience with systems such as LMS, ERP, etc. preferred
  • Ability to receive instruction and follow directions
  • Ability to interact positively with co-workers and management
  • Ability to communicate effectively with written and oral communication skills
  • Ability to follow company policies and procedures
  • Ability to follow cGMP and other regulatory requirements
  • Ability to read and interpret documents and make basic judgments on the suitability of received goods
  • Ability to operate and troubleshoot warehouse equipment
  • Detail oriented with ability to identify errors and/or inconsistencies while performing tasks

Problem Solving:

  • Works on assignments that are routine to semi-routine in nature where the ability to recognize deviation from accepted practice is required
  • Exercises judgment within specifically defined practices and policies and selects methods and techniques for obtaining solutions
  • Normally receives general instruction on routine work and detailed instruction on new assignments
  • May be asked to recommend methods and procedures for problem resolution

TRAVEL REQUIREMENTS


PHYSICAL REQUIREMENTS:

Constant:

  • Standing for extended periods of time at workstation or equipment
  • Walking to move short distances quickly and frequently

Frequent:

  • Stooping, Kneeling and/or Crouching – bending body, spine and/or legs
  • Grasping – applying pressure to an object with the fingers and palm
  • Using fingers to perform activities such as picking, pinching or typing
  • Climbing – use of feet, legs, hands and/or arms to ascend or descend
  • Repetitive Motions - frequent motions of the wrists, hands and/or fingers
  • Lifting – raising from lower to upper and/or moving objects horizontally – up to 50 lbs. and more than 50 lbs (with assistance)

Occasional:

  • Sitting for extended periods of time at workstation or mobile equipment

Visual Acuity:

  • Perform activities such as operating machines (i.e. lathes and drill presses) where the seeing job is at or within arm’s reach
  • Perform activities such as computer work, preparing and analyzing data, extensive reading, visual inspection involving small defects, small parts and/or operation of machines (including inspection), using measurement devices and/or assembly or fabrication of parts at a distance close to the eyes
  • Operate motor vehicles or heavy equipment

WORKING ENVIRONMENT

  • Frequent exposure to moderate to loud noise levels
  • Constant exposure to moving mechanical parts and/or moving equipment
  • May be required to wear personal protective equipment (PPE) as needed for assigned process (i.e. safety glasses, respirator, hearing protection, gloves, etc.)

We offer a competitive benefits package, including:

  • Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls
  • Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan
  • Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays
  • Life and Disability Protection: Company paid Life and Disability insurance
  • The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment
5. Functional - Key functional requirements set by hiring manager

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.


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Limitless High-tech career opportunities - Expoint
Responsible for providing a thorough and timely review and approval of cGMP documents and processes such as those related to deviations, investigations, equipment and facilities Maintenance and calibration, protocols and...
Description:

This role provides Quality Assurance support to Manufacturing, Supply Chain, and Quality Control Laboratories. Responsibilities include reviewing and approving QA methods, procedures, protocols, investigation documents, and change control documents. The position uses trend and investigational data to improve processes and reduce failures, while representing the quality department on cross-functional teams.


ESSENTIAL AREAS OF RESPONSIBILITY

• Responsible for providing a thorough and timely review and approval of cGMP documents and processes such as those related to deviations, investigations, equipment and facilities Maintenance and calibration, protocols and reports, and facility controls, instruments and procedures.
• Responsible for working with operating departments to facilitate process improvements and lean concepts.
• Responsible for participating in cross functional improvement and process monitoring teams to mitigate unfavorable trends.
• Responsible for providing first response and ongoing QA presence for quality and compliance issues on the manufacturing floor and as needed in the laboratories.
• Responsible for evaluating reports of deviations from defined processes and working with QA to determine if incidents should be escalated to an event investigation.
• Responsible for conducting comprehensive investigations of complex and/or challenging events as assigned.
• Responsible for completing all actions necessary in system to document investigations, identify root causes, create and assign appropriate CAPA’s and gain approval and closure of an event.
• Responsible for investigating critical events, supporting other quality team members in the analysis and documentation.
• Responsible for compiling and maintaining metrics and tracking logs for site’s quality KPI’s or other functions.
• Responsible for supporting activities within electronic systems as needed, such as LIMS, TrackWise, EAM
• Responsible for serving as QA backup as final review/release of production batch records.
• Responsible for completing training requirements and maintaining compliance with all assignments.
• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP’s) and Batch Record instructions.
• Responsible for performing additional related duties as assigned.


Your experience and qualifications

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.

Education/Certification/Experience:
• Requires a Bachelor’s Degree or equivalent with a minimum of three years relevant progressive QA experience in the pharmaceutical or a related industry.
• Prefer degree in Science or Engineering.
• Requires experience with and an in-depth knowledge of cGMP and other applicable industry regulatory requirements as they relate to the production of pharmaceutical products and associated quality systems.
• Requires experience with the handling of deviations, investigations and CAPA’s.
• Experience with Manufacturing/Quality systems such as Trackwise, Labware, Veeva, Learning Management Systems and statistical software preferred.
• Experience with laboratory related investigations/inquiries preferred.
• ASQ/CQE/CQA Certification preferred.Skills/Knowledge/Abilities:
• Detail oriented with ability to analyze information and create corresponding performance metrics.
• Computer proficiency with comprehensive working knowledge of MS Office products and computer relational databases.
• Ability to demonstrate sound judgment and decision making.
• Ability to build and maintain collaborative relationships between teams, departments and business units.
• Communicate effectively with excellent written and oral communication skills.
• Interact positively and collaborate with co-workers, management and external partners.
• Manage conflict and negotiate resolution.
• Self-directed with ability to organize and prioritize work.

Problem Solving:
• Proactively works on problems of a moderate to complex scope where evaluation of contributing factors requires the analysis of situations or data and an in-depth knowledge and evaluation of various known and unknown factors.
• Seeks out all resources when selecting methods and techniques for obtaining results.
• Acts independently and proactively to recommend and administer methods and procedures for problem resolution.

TRAVEL REQUIREMENTS
• N/A

PHYSICAL REQUIREMENTS:
Frequent:
• Using fingers to perform activities such as picking, pinching or typing.
• Repetitive Motions – frequent motions of the wrists, hands and/or fingers.
• Sitting for extended periods of time.

Occasional:
• Standing for extended periods of time at work station or equipment.
• Walking to move short distances quickly and frequently.
• Grasping – applying pressure to an object with the fingers and palm
• Lifting – raising objects from lower to upper and/or moving objects horizontally – up to 25 lbs.

Visual Acuity:
• Perform activities such as computer work, preparing and analyzing data, extensive reading, visual inspection involving small defects, small parts and/or operation of machines (including inspection), using measurement devices and/or assembly or fabrication of parts at a distance close to the eyes.

WORKING ENVIRONMENT:
• Occasional exposure to moderate to loud noise levels.
• Occasional exposure to moving mechanical parts or equipment.
• Occasional exposure to fumes, odors, dusts, mists, gasses or vibrations.
• May be required to wear personal protective equipment (PPE) as needed when in production areas (i.e. safety glasses, respirator, hearing protection, gloves, etc.).

We offer a competitive benefits package, including:
• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

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