Quality Analyst Ii jobs at Teva in United States, Salt Lake City

Data Governance & Backbone Enrichment

• Lead and manage data governance activities for the R&D analytical backbone.
• Support enrichment efforts across both backend and frontend layers of the analytical backbone.

Digital Platform Ownership

• Be assigned to relevant digital platforms and areas of need, including tools within the Microsoft 365 suite (e.g., Power BI, SharePoint, Power Automate) and AI-related platforms.
• Ensure platforms are effectively deployed, adopted, and maintained to meet business requirements.

Stakeholder Collaboration

• Collaborate closely with SHMs, Digital Leads, and cross-functional stakeholders to ensure alignment, adoption, and usability of digital tools and platforms.
• Act as a liaison between IT and business units to translate strategic needs into actionable digital solutions.

Within the scope of responsibilities:

• Drive implementations and continuous improvement of digital capabilities across R&D.
• Excels at cross-functional coordination – Working with IT, business units, vendors, and leadership.
• Maintain and enhance digital assets such as dashboards, SharePoint sites, and automation workflows.
• Facilitate knowledge sharing and training to promote digital literacy and platform usage.
• Participate in strategic planning and intake processes for new digital initiatives.
• Familiarity with Jira, Confluence & Sprints agile methodology

• Bachelor’s degree in Business or Software Engineering, or equivalent combination of education and related experience
• 2-3 years of experience as a business analyst managing multiple small to mid-sized projects with an understanding of digital offerings, including Power Platform, RPA and ML / AI capabilities
• Computer skills, especially with Project management software (Planisware, Jira, and/or Confluence), Excel, Powerpoint
• Must demonstrate ability to solve moderately complex problems and analyze and apply appropriate solutions. Identifies and solves problems by gathering and applying information from a variety of sources
• Project management skills in planning, milestone tracking & reporting
• Delivery oversight skillset mindset
• Stakeholder Management capabilities and customer facing approach.

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.

This position is responsible for performing operations related to the manufacturing of drug products through equipment set-up, operation, clean-up and maintenance in compliance with all regulatory requirements and company policies and procedures.

This position is to work in our Manufacturing Department from 3rd Shift, Monday through Friday 10:00 pm to 6:30 am.

ESSENTIAL AREAS OF RESPONSIBILITY

• Responsible primarily for set up, changeover and operation of fluid bed and/or encapsulation. Additional duties include, but not limited to, mixers, granulators, dryers, mills and tablet compression.
• Responsible for demonstrating consistent and proficient performance in certified areas of operation as applicable.
• Responsible for demonstrating consistent and proficient performance on routine troubleshooting of machine parts and equipment in certified areas of operation as applicable.
• Responsible for training lower level technicians to perform manufacturing operations as applicable.
• Responsible for cleaning facilities, equipment and utensils as required following written Standards Operating Procedures and Work Instructions.
• Responsible for completing documentation as required in the manufacturing of product and the cleaning of facilities and equipment, following cGMP’s and good documentation practices.
• Responsible for reporting and/or escalating any conditions or problems that may affect the quality or integrity of product.
• Responsible for completing all 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.

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.
• Requires fluid bed and/or encapsulation experience in industries such as pharmaceutical, food processing or chemical manufacturing.
• Prefer Teva certification in one or more MFG and/or PKG operations as applicable for position.

Skills/Knowledge/Abilities:
• Basic computer skills with working knowledge of MS Office products, Learning Management Systems (LMS), ERP systems such as SAP or Oracle and manufacturing/quality systems such as Trackwise and Qdocs.
• 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 operate and troubleshoot production 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.

PHYSICAL REQUIREMENTS:

Constant:
• Standing for extended periods of time at work station or equipment.
• Walking to move short distances quickly and frequently.
• Fingering – using fingers such as picking, pinching or typing.

Frequent:
• Stooping, Kneeling and/or Crouching – bending body, spine and/or legs.
• Twisting/Reaching – turning at waist and extending hands and/or arms in any direction.

Occasional:
• Sitting for extended periods of time at work station or mobile equipment.
• Climbing – use of feet, legs, hands and/or arms to ascend or descend.
• Crawling – using hands and knees or hands and feet to move about.
• Pushing and/or Pulling – using upper extremities to exert force.
• Grasping – applying pressure to an object with the fingers and palm.
• Repetitive Motions - frequent motions of the wrists, hands and/or fingers.
• Lifting – raising from lower to upper and/or moving objects horizontally – up to 25 lbs, up to 50 lbs. and more than 50 lbs (with assistance).

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

• Constant exposure to moving mechanical parts and/or moving equipment.
• Frequent exposure to moderate to loud noise levels.
• Frequent exposure to fumes, odors, dusts, mists and/or gasses.
• Frequent exposure to vibrations.
• Occasional exposure to wetness depending on assigned process.
• 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.
• 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.

• Execute strategies to achieve both national and individual goals and quotas within your assigned region
• Maintain a working knowledge of the biosimilar, specialty, and generic pharmaceutical industries, including contracting, distribution/wholesaler channels, pricing structures, chargeback programs, institutional sales, group purchasing organizations (GPOs), Integrated Delivery Networks (IDNs), clinics, buy & bill models, reimbursement, and market access
• Understand formulary and P&T processes for assigned customers—including clinics, IDNs, and specialty pharmacies—to support formulary access for targeted Teva products
• Enter all account and customer activity into the Teva CRM system (Veeva) on a daily basis
• Penetrate assigned customer targets at all levels to build relationships that support strategic objectives
• Analyze your region as a business unit using Teva-provided resources, including preparing and presenting quarterly business reviews
• Collaborate effectively with members of the National Account team, Marketing, and Management to achieve distribution and sales objectives
• Represent and promote Teva’s products and image professionally and productively, while adhering to compliance, aggregate spend, and travel policies
• Record account information and competitive intelligence using available resources

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 required; Master’s degree preferred
• Minimum of 5 years of professional experience in Account Management, Sales, or Marketing, or at least 2 years of experience in the pharmaceutical industry
• Experience in the buy & bill market, preferably in the biosimilar space, is preferred
• Experience working in hospital or IDN markets is preferred

Skills/Knowledge/Abilities:

• Proven track record of superior sales results and strong business acumen
• Knowledge of pharmaceutical reimbursement and the 340B
• Strong negotiation skills
• Strategic thinking and ability to understand and execute strategy
• Experience in delivering and executing contracts

Travel requirements:

• Up to 50% travel required
• Incumbent must live within 60 miles of the workload center within their assigned territory

Physical requirements:

• Ability to sit for extended periods at a workstation or while operating mobile equipment
• May be required to wear personal protective equipment (PPE) during site visits (e.g., safety glasses, hearing protection, gloves)

Credentialing Requirements: Employees in customer facing roles will be required to complete all Teva customer credentialing requirements for access to their customers within 60 days of their start date. The employee will be required to upload proof of immunization to the credentialing vendor system within 60
days of notification of requirement. Such credentialing requirements may include, but are not limited to, additional vaccinations, medical testing and customer facility safety training.

The annual starting salary for this position is between $134,800 - $176,900 annually. Factors which may affect starting salary within this range and level of role may include geography/market, skills, education, experience and other qualifications of the successful candidate.

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, 13 paid Holidays and 3 paid floating holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but 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.

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.

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.

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.

• 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.

• 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.

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.

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.

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.

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.

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.