Senior Quality Assurance Specialist

Pfizer • Rochester, MI

1d • Onsite

About The Position

USE YOUR POWER FOR PURPOSE Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients. WHAT YOU WILL ACHIEVE In this role, you will: Evaluate and review clinical and commercial drug batches to ensure compliance with established specifications. Conduct rigorous sampling and statistical process control procedures to identify deviations from standards. Approve investigations and change control activities to maintain compliance with configuration management policies. Contribute to moderately complex projects, managing time effectively and developing short-term work plans. Independently assess Change Control activities for potential Quality and Operational Good Manufacturing Practices (cGMP) impacts. Investigate and document Quality Assurance deviations, escalating issues to the Quality Assurance Lead as needed. Ensure regulatory compliance with current Good Manufacturing Practices (GxP) and provide Quality Review and oversight of site documentation to meet global regulatory and Pfizer quality standards.

Requirements

• Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with more than 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.
• Solid understanding of current Good Manufacturing Practices and relevant GxP regulations and standards.
• Strong critical thinking skills.
• Ability to work effectively within own team and interdepartmental teams.
• Good working knowledge of Microsoft Excel and Word.
• Proactive approach to problem-solving.
• Must be able to aseptically gown.
• This is a penicillin manufacturing facility. All candidates applying mist NOT be allergic to penicillin.
• Able to lift 25-30 lbs.

Nice To Haves

• Experience in quality administered systems.
• Strong organizational skills and attention to detail.
• Experience with regulatory compliance and documentation.
• Ability to mentor and review the work of other colleagues.
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity.
• Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use.

Responsibilities

• Evaluate and review clinical and commercial drug batches to ensure compliance with established specifications.
• Conduct rigorous sampling and statistical process control procedures to identify deviations from standards.
• Approve investigations and change control activities to maintain compliance with configuration management policies.
• Contribute to moderately complex projects, managing time effectively and developing short-term work plans.
• Independently assess Change Control activities for potential Quality and Operational Good Manufacturing Practices (cGMP) impacts.
• Investigate and document Quality Assurance deviations, escalating issues to the Quality Assurance Lead as needed.
• Ensure regulatory compliance with current Good Manufacturing Practices (GxP) and provide Quality Review and oversight of site documentation to meet global regulatory and Pfizer quality standards.

Benefits

• 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: Mid Level
• Number of Employees: 5,001-10,000 employees