דרושים Quality Assurance Specialist ב-United States, Pennsylvania, West Whiteland Township

In this role, the Quality Project Manager will support the standardization of QMS process and data management across the organization. This position will lead the development and deployment of quality maturity, QMS improvements and quality cost related measures, evaluations, performance, and initiatives. This position will coordinate activities associated with quality maturity including continuous improvement projects relating to sustaining engineering activities, development of new methods/processes for product evaluation and product development activities through a standardized approach. In addition, this position will deploy highly capable, predictive, effective, and efficient quality cost metrics for West Pharmaceuticals. This position will also be responsible for leading and executing cost improvement initiatives, follow up assessments and action oversight.

• Lead the initiative to standardize quality systems between multiple sites. Identify best practices and ensure roll out to relevant sites.
• Organize and generate detailed quality information reports to show trends and the impact of process improvements.
• Create repeatable methods to assess, measure and communicate the overall quality of a project and deliver key metrics to assess the overall improvement.
• Establish and lead cross functional quality related meetings to review and discuss performance, status and prompting necessary actions as required.
• Manage goals and metrics for Quality teams/initiatives to adequately monitor the overall effectiveness of the teams/initiatives.
• Work with project managers, engineering team, and platform management to develop plans to implement improvement projects.
• Ensures teams work closely with product development, supplier/contractors, design, quality, regulatory teams in order to establish standardized KPIs.
• Work within Quality or across West Divisions to triage Customer Operational difficulties, define root cause(s), and coordinate the implementation of corrective and preventive actions to preclude recurrence related to quality improvements and quality maturity.
• Manage or contribute to both corporate and facility driven initiatives intended to meet defined objectives.
• Support front room and or backroom responsibilities during external audits. Including post audit activities, if required.
• Responsible for assembling a project team, assigning individual responsibilities, identifying appropriate resources needed, and developing schedules to ensure timely completion of project.
• Record detailed customer requirements, constraints, and assumptions with stakeholders in order to establish the project deliverables.
• Responsible for project budget estimation, monitoring, and attainment throughout the project lifecycle.
• Ensure a common understanding by setting expectations in accordance with the project plan in order to align the stakeholders and team members.
• Lead the identification, assessment, monitoring, and closure of project risks throughout the project lifecycle.
• Manage changes to the project scope, project schedule, and project costs using appropriate verification techniques in order to keep the project plan accurate, updated, and reflective of authorized changes to facilitate customer acceptance.
• Responsible to improve team performance by building team cohesiveness, leading and motivating in order to facilitate cooperation, ensure project efficiency, and boost morale.
• Measure project performance using appropriate tools and techniques in order to monitor the progress of the project, identify and quantify any variances, perform any required corrective actions, and communicate to all stakeholders.
• May coordinate the activities of one or more exempt and/or non-exempt employees.
• All other duties as required.

• Bachelor's Degree in Science, Engineering or related field

• 8+ years of relevant work experience required

• 5+ years’ experience in pharmaceutical or medical device environment.
• 2+ years’ experience in a Quality role.
• ASQ CQE certification desirable.
• Deep knowledge of quality processes such as CAPA, complaint management, risk management, root cause analysis, statistical sampling plans, FMEA/Fault Tree Analysis, Design Optimization using DOE, Hardware Reliability, Software Reliability, and Design Controls including Design Verification/Validation.
• Knowledge of ISO 9001:2008, ISO 13485, 21 CFR 820, 21 CFR 210 & 211, cGMP, cGLP.
• Ability to manage direct report(s), work independently and in a team environment.
• Demonstrate innovativeness in tactical matters relating to proposing alternate solutions for process improvement.
• Experience in FDA regulated environment, pertinent to ISO 13485 is preferred.
• Experience with SAP is preferred.
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
• Able to comply with the company’s safety policy at all times.
• Able to comply with the company’s quality policy at all times.

The Sr. Specialist, Regulatory Affairs, Medical is responsible for influencing department regulatory processes and procedures, developing strategies, authoring, reviewing, and supporting global registrations, including Premarket Notifications, China NMPA Registrations, Technical Documentation for CE Marking, and technical packages. The Sr. Specialist ensures timely and high-quality execution of all regulatory deliverables.  In addition, the Sr. Specialist mentors team members and ensures compliance with West Pharmaceutical Services, Inc. (West) and government requirements. This position includes supporting internal and external customer regulatory requests.

• Develop and implement medical device regulatory strategies for West’s administration and safety system product portfolio with an emphasis on gaining regional regulatory approval/clearance/licensure for medical devices in an efficient, compliant manner.
• Author and review US, EU, and additional international submissions with guidance for new products and product changes as required to ensure content accuracy, compliance with applicable regulations, and timely approvals for market release.
• Provide technical review of data and or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation.
• Provide leadership to cross functional teams for regulatory issues and questions.
• Compile and maintain regulatory documentation databases or systems as well as technical documentation required for new or modified products.
• Create documentation in response to customer regulatory requests which includes regulatory letters, technical packages, etc.
• Clearly and effectively communicate team/project progress/status, decisions, timelines, etc. to RA management, internal and external customers.
• Develop specific objectives and manage work assignments, with minimal guidance to achieve personal objectives in conformance with overall business goals
• Adhere to all applicable government and West regulations, practices, and procedures to maintain compliance
• Maintain working knowledge of computer software packages including MS Word, MS Excel, MS Teams, MS PowerPoint, Master Control, Adobe, SharePoint, and others as required

• Bachelor’s degree or equivalent experience is required
• Master’s degree or PhD in science, math, engineering, or related discipline preferred

• Minimum 5 years of relevant experience
• 2+ years of medical device regulatory experience preferred
• Experience with US FDA regulations (Title 21CFR820), EU MDD (93/42/EEC) and EU MDR (2017/745)
• History of successful international device registration,EU MDR technical documentation and/or US 510(K) authoring experience
• Advanced knowledge of ISO 13485
• Advanced knowledge of product life cycle, product development process, design control and change control
• Experience interacting with government agencies
• Excellent oral communication, technical writing, and decision-making skills

• Attention to detail with planning, time management and organizational skills
• Regulatory compliance competency including Quality Systems
• Experience with administration and safety systems preferred
• Ability to triage and manage work priorities and to follow established processes while identifying areas for process improvement.

• Ability to comprehend principles of math, science, engineering, and medical device use.
• Ability to handle technical reports, drawings, specifications, regulatory and quality documentation with a high degree of confidentiality.
• Ability to research, read, analyze, and interpret regulatory literature and documentation, regulations, technical standards, guidance documents, test reports, clinical/medical terminology, technical product information, and complex documents.
• Ability to review, collate, describe, and summarize scientific and technical data.
• Ability to organize complex information and combine pieces of information to form general rules or conclusions.
• Ability to utilize judgment and make decisions considering the relative risks and benefits of potential actions to choose the most appropriate one.
• Ability to assess, plan, schedule and manage multiple long-term and short-term projects, tasks, responsibilities and/or priorities in a concurrent fashion with several parallel deliverables and execute deliverables to time-line commitments.
• Ability to be an effective team member and work well with others in a team environment on cross-functional and/or matrix teams.
• Ability to be flexible with changing priorities and comply with constantly changing regulatory procedures.
• Ability to build strong relationships both internally and externally. Ability to work in a fast-paced environment.
• Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above.
• Ability to verbally communicate ideas and issues effectively to other team members and management.
• Ability to write and record data and information as required by procedures.
• Proficiency in the use of personal computers and computer programs, particularly, Microsoft Office Suite: Excel, Word, PowerPoint, and Adobe Acrobat (or equivalents if changed by the Company).

• Regulatory Affairs Certifications (RAC)-RAPS R.A.C certification(s) preferred

In this role you will be responsible for performing Supplier Quality activities associated with external suppliers. This role performs activities to ensure West supplier’s maintain compliance with West’s procedures and policies. You will interface with R&D, Sourcing, Design Quality, Regulatory and Operations Quality to drive improved supplier quality performance.

• Establish and successfully executesupplier management planswhich will align to overall business objectives

• Maintain a strong collaborativepartnership

• supplier performanceincluding incoming failures, manufacturing yields and field failures to drive Supplier Corrective Action Reports (SCARs)

• ExecuteSupplier Corrective Action Requests(SCAR) with suppliers, ensuring effective and timely closure

• Work with suppliers, R&D, and Sourcing on continuous improvement of supplier performance includingsupplier changerequest.

• Evaluate potential new or future suppliers and support supplierselection processwith the cross-functional team

• Participate in cross-functional teams of design engineering and quality engineering to work with suppliers duringproduct developmentand ensures agreement for manufacturable, cost-effective designs

• Approves components for use in products by drivingProduct Approvalactivities with the suppliers

• Supports Supplier evaluation,auditmanagement and related records

• Supports the evaluation and development ofQuality Agreements and purchasing specificationswith suppliers

• Support the development of anIncoming Inspection strategyon purchased products

• Bachelor's Degree In Engineering or Science required
• Master's Degree In Engineering or Science preferred

• Minimum 5 years of quality related experience with preferred experience in pharmaceutical and/or medical device industry

• Experience working with suppliers and supplier engagement activities

• Knowledge of sterilization process is preferred

• Knowledge of cGMP, cGDP, relevant ISO standards, medical device requirements and other international regulations

• Familiarity with MasterControl, SAP and working knowledge of statistical data analysis

• Fluent in English

• Thorough understanding of validation activities and risk management principles and techniques

• Strong problem-solving and critical thinking skills

• Negotiation skills and collaborating with suppliers

• Ability to work under high volume production and fast changing environment

• Willingness to work in a cross-functional team with different time zones

• Able to comply with the company’s safety policy at all times.

The Sr Manager, ESG Strategy & Support will act as a key strategic partner in leading and shaping the Environmental, Social, and Governance (ESG) program at West. This pivotal role involves embedding ESG considerations into West's business processes while aligning with its Mission, Vision, and Values. Responsibilities include ensuring compliance with ESG-related laws and regulations such as CSRD, CDP, EU Deforestation, SBTi, CBAM and GRI. The role functions to support the ESG program and involves close collaboration with team members to establish strategies and devise global, regional, and local plans that align with West's Global ESG goals.

• In depth collaboration with internal stakeholders to deliver, drive and execute on ESG goals including Climate strategy; Waste in operations; R&D for the environment; Responsible supply chain
• Serve as the “go-to” ESG subject matter expert for assigned business functions, which may include operations, commercial, supply chain, and research & development projects.
• Champion the creation and release of the annual ESG report, working with Communications and Data Collection and Reporting teams.
• Drive the Science-Based Target Initiative (SBTi) strategy.
• Ensure conformity to global ESG-related laws and regulations (voluntary and mandatory) reporting standards while spearheading program enhancements and monitoring ESG reporting best practices and evolving legislative/regulatory regimes.

• Establish robust procedures and systems for dialogues with internal and external stakeholders concerning ESG issues, including assessment and development of ESG policies, processes, and systems where appropriate.
• Proven track record in analyzing and communicating complex ESG data to a wide variety of stakeholders, delivering strategic insights to senior executives.
• Augment engagement with primary customers and investors, ensuring timely and effective responses to all ESG-related inquiries.
• Tackle other role-related tasks as necessitated by the organization, strictly observing all organizational guidelines, policies, and safety regulations.
• Other duties as assigned.

• Bachelor's degree in environmental or other sciences, or related fields (required).
• Master’s degree in business, environmental sciences or related fields (preferred)

• Minimum 10 years in ESG or sustainability-related roles, with preferred experience in SBTi and emissions calculations (required).

• Familiarity with or experience implementing operational and / or supplier environmental and human rights risk analysis and due diligence processes.
• Experience using and / or implementing Product Carbon Footprint (ISO 14067, PATH) / LCA.
• Demonstrated ability to engage R&D organizations to implement sustainability-related considerations into product development / stage gate processes.
• Have an established network within the ESG community to engage with thought leaders and regulatory bodies.
• Experience with SBTi and Scope 1, 2 and 3 emissions calculations.
• Experience with ESG reporting software such as NASDAQ OneReport, Metrio.
• Advanced knowledge of the depth and breadth of sustainability-related ranking organizations such as UN Sustainable Development Goals, CDP, and SASB reporting requirements.
• Advanced level skill in MS Excel, Power Point, Word, and Outlook.
• Advanced knowledge of the depth and breadth of sustainability-related ranking organizations such as DJSI and CDP.
• Extremely detail-oriented and deadline driven, with proven track record.
• Excellent communication skills, both written and oral, with proven track record.
• Excellent organizational, administrative, and time-management skills with the ability to work effectively under pressure.
• Exceptional ability to immediately establish credibility with senior executives.
• Ability to independently manage projects and solve problems quickly and effectively.
• Proven ability to cultivate teamwork and fill knowledge or skill gaps where needed.
• Ability to build and maintain strong relationships with customers, business partners, resource managers, and other senior-level executives.
• Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description.
• Ability to manage multiple tasks/projects/priorities and simple systems simultaneously.
• Ability to exercise good judgment and maintain a high level of integrity.
• Ability to comply with the company’s safety and quality policy at all times.

• Communication, quick decision making based on logic, circumstances and data at hand, interpreting data, reading or writing, public speaking - must be able to express or exchange ideas with team members.

• Must be able to understand direction and adhere to established procedures.
• Must be able to communicate effectively, speak in front of groups, express & exchange ideas and understand direction.
• Maintain the ability to work well with others in a variety of situations.
• Able to learn and apply new information or new skills.

• Read, interpret and analyse data, information and documents.
• Must be able to multi-task, work under time constraints, problem solve and prioritize.
• Must be resilient.
• Demonstrates enthusiasm, takes accountability, is “self-started” and takes initiative for all work and is results driven.

The Project Specialist, Metrology is responsible for managing the West Services and Solutions (WSS) CAPEX program from planning and initiation through asset registration and implementation. You will be responsible for identifying and aligning stakeholders from cross-functional teams, creating, maintaining, and reporting project schedules, forecasting, updating, and reporting on financials associated with each project, and coordinating the WSS CAPEX items within the overall Global Quality Laboratory CAPEX budget. Responsible for driving projects to completion based on timelines, budget, and resources.

• Create and maintain the yearly WSS CAPEX program schedule for all items approved for the CAPEX budget
• Hold regular project meetings with cross-functional stakeholdersCreate and maintain detailed project schedules (Gantt or similar)
• Facilitate alignment of timelines, responsibilities, and deliverables in accordance with procedures
• Follow escalation procedure for delayed/impacted projects and Track project milestones
• Report project status highlighting risks and opportunities for improvement
• Track and report financials associated with each CAPEX project
• Coordinate with WSS Lab Purchasing, WSS Metrology, Global Technical Projects, Global Finance, and Quality Laboratory to establish and provide accurate
  • forecasting and closure of projects
  • Track and report budget adherence
  • Manage resource allocation and communication for the program
• Ensure appropriate resources have been committed to each project working with management when there are conflicts
• Maintain a clear and unambiguous communication plan with all stakeholders and management for expectations, commitments, timelines, deliverables, responsibilities, and status
• Proactively identify and facilitate resolution of all project-related issues
• Management/initiation of associated administrative details: initiating change controls assigning tasks, resources, and timelines, requesting the initiation of required documents, general administrative tasks to keep the projects on track
• Implement change management processes, when needed, to align with shifting requirements and priorities
• Support the WSS Metrology team with routine tasks, as needed

• Bachelor's Degree in a related area or equivalent experience
• Minimum 2 years of experience in metrology/analytical instrumentation in a cGMP environment, preferred
• Minimum 2 years of experience in project management, preferred

• Demonstrated ability to multi-task and manage multiple projects simultaneously
• Strong understanding of a cGMP environment
• Experience with Quality Management Systems
• Dependable, highly organized, detail oriented, able to think creatively under pressure and work in a fast-paced, constantly changing environment
• Excellent written and verbal communication skills
• Familiarity with SAP
• Experience with project management tools such as MS Project
• Able to comply with the company’s safety and quality policies at all times

• Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Position operates in a professional office environment. May stand or sit for extended periods of time
• Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read & write, speak in front of groups, express & exchange ideas, understand direction and adhere to procedures
• Organizational skills will enable planning, prioritization & achievement of goals especially of importance for the successful execution of related activities

• Project Management Certificate, such as CAPM, preferred

• Prepare journal entries related to manufacturing accounting and inventory reserves to support accurate and timely financial statements in accordance with US GAAP and corporate financial policies
• Process manufacturing orders as part of the month-end close process
• Participate in other monthly close activities for plants in area of responsibility
• Prepare account reconciliations to ensure proper balance sheet valuation
• Calculate standard costing of products in SAP as part of new product workflow
• Monitor variances to standard cost and correct any erroneous errors
• Support the periodic cycle count process
• Reconcile 3rd party warehouses
• Ensure appropriate controls and compliance with US GAAP
• Support and assist other functions within the business as required

• Bachelor's Degree Accounting or Business with concentration in Accounting/Finance or equivalent experience required

• Minimum 3 years Accounting required

• Accounting experience, preferable in a manufacturing environment using SAP or other ERP
• Understanding of GAAP and internal control principles
• Highly proficient in written and spoken English
• Working knowledge of MS Office or the willingness to learn it quickly with highly proficient Excel skills
• Strong communication skills
• Strong people skills – approachable, good listener, empathetic
• Strong learning capacity
• Ability to work independently in global environment
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Able to comply with the company’s safety and quality policies at all times

• Must be able to understand direction and adhere to established procedures
• Must be able to communicate effectively, speak in front of groups, express and exchange ideas and understand direction
• Maintain the ability to work well with others in a variety of situations
• Able to learn and apply new information or new skills
• Read and interpret data, information and documents
• Must be able to multi-task, work under time constraints, problem solve, and prioritize
• Ability to make independent and sound judgments
• Demonstrates enthusiasm, takes accountability and drives for results
• #LI-JJ1 #LI-HYBRID

The Physiochemical Testing group strives to deliver creative medicines to patients through performance fundamental chemical, physical and structural testing within a GxP-compliant QC laboratory to support preclinical and clinical production as well as commercial launch. Primary responsibilities center on being able to develop, implement and manage departmental strategies for physiochemical testing with respect to product in-process, release and stability testing, raw materials testing, contract lab testing, and regulatory submissions. The incumbent may also participate in/provide oversight of activities related to the management of CGMP analytical method lifecycle (e.g. management of reference standard, assay control, critical reagents and materials, product specification and sampling plan processes). The incumbent should possess a practical understanding of bio-pharmaceutical drug development and GxP requirements as knowledge of local, regional and global regulatory compliance (ICH, GMP, EPA, OSHA, DEA, etc.) are integral responsibilities of this position.

Overseeing QC laboratory operations by managing a team of professionals and junior managers who execute physiochemical CGMP testing.
Establishing and maintaining strategies for method and/or process implementation, continuous improvement initiatives, and method transfer and validation processes.
Developing strategies and approaches for special studies, as applicable.
Ensuring compliance with applicable ICH, GxP and safety regulations as an individual contributor as well as an educator and manager of junior staff. Executional tasks include but are not limited to:
• Supporting general GxP and data integrity compliance in both routine and non-routine work activities for both internal and external contract lab testing. This includes efforts as an individual contributor that may include but are not limited to the review and approval of data in raw and reported forms as well as training staff in compliance or technical principles
• Providing oversight and/or support of QC lab investigations, audits, inspections, and communications with regulatory agencies and health authorities
• Providing support for staff who identify, write, revise, manage and implement standard operating procedures, work instructions, standard practices, protocols, and reports. Executing these tasks as an individual contributor, as applicable
Engaging, coaching, motivating and empowering staff to ensure their skills match their roles and to continually develop, thereby improving productivity and efficiency of the department operations.

Education
Minimum: BS/MS in relevant discipline
Preferred: PhD in Biochemistry, Analytical Chemistry

Experience
10-15+ years (BS/MS/PhD) in the (Bio)pharmaceutical industry with deep technical knowledge in physiochemical testing applications and one or more areas of drug development

Specialized Knowledge:
LIMS, TrackWise or VEEVA Quality Management Systems, Documentum Based Systems

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.

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