Quality Associate, Operations
PfizerAbout the role
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.
What You Will Achieve
In this role, you will:
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.
Here Is What You Need (Minimum 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 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
Bonus Points If You Have (Preferred Requirements)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
PHYSICAL/MENTAL REQUIREMENTSGood 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.).
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS- This role is primarily a Wednesday - Saturday schedule (4/10s), with 24/7 support of manufacturing as quality issues arise (10 am - 8 pm)
Work Location Assignment: On Premise
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