Sr. Associate - QA Operations

Location

United States - Missouri - St. Louis - Chesterfield

We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.

To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.

Pfizer Global Supply proudly shoulders the responsibility of manufacturing and distributing our wide-ranging pharmaceutical products.

Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.

Transforming Delivery of high quality products

Pfizer, We are one

PGS - Manufacture the Future

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.

In your role, you have the all-important task of providing Quality Assurance oversight to GMP manufacturing and testing operations for clinical drug substance, intermediates, and starting materials. This includes quality oversight of technology transfer and disposition deliverables such as review of batch records, investigations, CAPAs, SOPs, test methods, change controls, and release of drug substance, intermediates, and starting materials (e.g. cell banks).

Your skills will help you collaborate and implement practices and gain efficiencies throughout quality procedures and R&D documentation.

As a Sr. Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing important deliverables on time. Your innovative use of communication tools and techniques will make it easy to manage difficult issues and help in establishing consensus between teams.

It is your dedication and hard work that will make it possible for Pfizer’s customers and patients to receive the medicines they need, when they need them.

• Contribute to the completion of complex projects, manage own time to meet agreed targets, and develop plans for work activities on own projects within a team.
• Review and/or approve various GMP documents, primarily batch records and investigations and including procedures, change controls, validation qualifications, and CAPAs.
• Perform quality assurance disposition function for raw materials, in-process solutions, and/or production batches.
• Evaluate applicable corrective and preventive action responses to the audit findings for adequacy and timeliness.
• Participate on technology transfer teams reviewing and approving master batch records and related documentation.
• Support the site relative to a constant state of inspection readiness.
• Participate in audits relative to this role as needed.
• Make quality decisions to resolve moderately complex issues with minimal assistance from management.
• Recognize when an issue is beyond their sphere of influence and elevate immediately.
• Present to peers/management locally or electronically.
• Contribute to quality assurance management team initiatives and objectives.
• Provide review of equipment/instrument validation documentation and related calibration documentation, as needed.
• Participate on special projects, limited duration teams, and local or global initiatives such as continuous improvement teams for Quality Assurance.
• Participate in quality risk management activities.
• Assist in the process of gathering, interpreting and applying statistical methods to various Production/Quality related processes and communicate those through reports, memos, files and presentations.
• Assist in the review of area documentation and perform trend analysis on data, controls and standards.
• Responsible for knowing, understanding and acting in accordance with Pfizer’s values.
• Demonstrate strong…