Sr. Associate - QA Operations

Pfizer • Chesterfield, MO

8d • Hybrid

About The Position

Use Your Power for Purpose Pfizer is driven by an unwavering commitment to delivering safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Your contributions will be vital and will have a direct impact on patient care, ensuring we deliver on our promise of quality and safety. Why Patients Need You 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 You Will Achieve 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.

Requirements

• Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with 0+ years of experience; OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience
• Demonstrated skills in conducting and documenting quality investigations related to pharmaceutical or medical device manufacturing processes
• Understanding of cGMP, Data Integrity.
• Strong understanding of Quality System functions, manufacturing and/or packaging processes
• Excellent technical writing, communication, and presentation skills
• Proficiency in Microsoft Office, Microsoft Project, and Statistical Software
• Experience in preparing and participating in audits and inspections

Nice To Haves

• ALCOA principles
• Strong analytical and problem-solving skills
• Ability to work independently and as part of a team
• Strong interpersonal skills and the ability to communicate effectively with all levels of the organization
• Ability to adapt to changing priorities and manage multiple tasks simultaneously
• Experience in mentoring and training colleagues

Responsibilities

• 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 escalate 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 interpersonal, teamwork, and collaboration skills.

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.
• Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com).

What This Job Offers

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