Quality Associate, Operations

Use Your Power for Purpose
Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver is of the highest standard.

Your role is crucial in maintaining this commitment and driving forward our mission to improve patient outcomes.

• Perform on-the-floor QA tasks within the manufacturing areas as needed, collaborating with manufacturing and other departments to provide routine quality support, and maintain inspection readiness.
• Conduct on-the-floor QA review of executed batch records and other manufacturing documentation to ensure adherence to site procedures, regulatory standards and filing requirements.
• Provide triage support across departments to address quality issues, ensuring timely escalation to management when necessary.
• Review and approve deviations, including the associated investigation reports, and corrective/preventative actions.
• Author, review and approve SOPs as appropriate for both Operations and Quality.
• Assist with additional tasks, including (but not limited to) Master Data management / approval, GMP area walkthroughs, product changeover activities.
• Participate in internal audits, support regulatory inspections or corporate audit activities, as needed.

• 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 the pharmaceutical industry and Quality administered systems.
• Sound knowledge of current Good Manufacturing Practices (part of GxP).
• Ability to work effectively in a team environment, both within one’s own team and interdepartmental teams.
• Effective written and oral communication skills.

• Experience at a manufacturing site.
• Managing and writing deviations.
• Experience in production batch record review, Enterprise Resource Planning system, investigation of non-conformance, root cause analysis and change control management.
• Strong problem-solving skills.
• Ability to work independently and as part of a team.
• Excellent time management and multitasking abilities.
• Effectively manages stressful situations, able to focus on task at regardless of circumstances and stress induced pressure.

• Good judgment and correct decision making based on company procedures/standards, technical experience, and industry guidance / regulatory requirements.
• Collaboration skills and the ability to independently engage with a wide range of colleagues, and management to gather the input and background knowledge needed to complete assignments.
• Must be able to gown for entering controlled areas.
• Must be able to wear specialized protective clothing, wear PPE (safety shoes/glasses/etc.).

This role is primarily a Wednesday – Saturday schedule (4/10s), with 24/7 support of manufacturing as quality issues arise (10 am – 8 pm).

On Premise

The annual base salary for this position ranges from $66,500.00 to $. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 7.5% of the base salary. 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.

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