Quality Assurance Specialist

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.

In this role, you will:
Evaluate and review clinical and commercial drug batches to ensure quality. Ensure product and process documents meet established specifications through rigorous sampling and statistical process control. Identify and address deviations from manufacturing and packaging standards. Approve investigations and oversee change control activities to maintain compliance with configuration management policies. Contribute to project tasks and milestones, organizing work to meet deadlines.

Learn and apply basic team effectiveness skills within the immediate work team. Make decisions within limited options to resolve basic problems under supervisor's direction. Ensure manufacturing and packaging records conform to Pfizer policy and cGMP standards. Maintain inspection readiness, support regulatory and customer inspections, and improve quality assurance systems. Assist manufacturing/packaging staff in real-time compliance error detection and resolution, and lead or participate in Quality Risk Management assessments.

Bachelor's degree with any years of experience, or an Associate's degree with 4 years of relevant 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 Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance

Expected to spend time between office and shop floor as needed to support manufacturing. This is a penicillin manufacturing facility. Any candidates applying must NOT be allergic to penicillin.

This is a first shift position ). The selected candidate will be required to support manufacturing as needed and be on premise for occasional weekend shifts. Relocation support available

On Premise

The annual base salary for this position ranges from $68,600.00 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…