QA Associate

Pfizer • Andover, MA

8d • Onsite

About The Position

Use Your Power for Purpose Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients. What Will You Achieve You will be responsible for activities involved in developing and maintaining quality programs, processes and procedures that ensure compliance with established standards and agency guidelines. Your contribution in quality risk management will help us in commitments tracking, interpreting policies, manage site complaints and work directly with operating entities to provide process analyses oversight. In this role, you will: Responsibilities include: Support quality oversight for utilities, manufacturing processes, laboratory operations, and/or related computer systems to ensure the successful disposition of clinical trial materials. Review/Approve documentation pertaining to standard operating procedures, equipment validation, maintenance, and/or calibration activities. Review/Approve quality records such as investigations, and commitments. Support compliance and inspection readiness activities. Support documentation life cycle activities. How You Will Achieve It Participate, lead/co-lead continuous improvement initiatives. Ensure operations and/or procedures are following regulations and Pfizer standards. Ensure continuous inspection readiness through facility walkthroughs. Manage quality topics and make quality decisions with the support of manager. Support/Manage disposition of clinical trial materials and all related materials. Communicate and influence across site and department boundaries for compliant adherence. Network internally to maintain effective business relationships with colleagues. Support documentation life cycle activities such as procedure administration and/or active library activities.

Requirements

• Applicant must have a bachelor's degree with 0+ years of experience; OR an associate's degree with 4 years of experience; OR a high school diploma (or equivalent) and 6 years of relevant experience
• Experience in pharmaceutical manufacturing and/or Quality.
• Ability to handle multiple tasks concurrently and in a timely manner.
• Excellent written and verbal communication skills.
• Advanced computer skills in MS Office applications and good knowledge of enterprise systems.

Nice To Haves

• Proactive approach and strong critical thinking skills.
• Experience in audit and inspection.

Responsibilities

• Support quality oversight for utilities, manufacturing processes, laboratory operations, and/or related computer systems to ensure the successful disposition of clinical trial materials.
• Review/Approve documentation pertaining to standard operating procedures, equipment validation, maintenance, and/or calibration activities.
• Review/Approve quality records such as investigations, and commitments.
• Support compliance and inspection readiness activities.
• Support documentation life cycle activities.
• Participate, lead/co-lead continuous improvement initiatives.
• Ensure operations and/or procedures are following regulations and Pfizer standards.
• Ensure continuous inspection readiness through facility walkthroughs.
• Manage quality topics and make quality decisions with the support of manager.
• Support/Manage disposition of clinical trial materials and all related materials.
• Communicate and influence across site and department boundaries for compliant adherence.
• Network internally to maintain effective business relationships with colleagues.
• Support documentation life cycle activities such as procedure administration and/or active library activities.

Benefits

• We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments.
• Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees