Description
At Pfizer, you will play a crucial role in evaluating and reviewing clinical and commercial drug batches to ensure quality. Your responsibilities include:
- Evaluating and reviewing clinical and commercial drug batches to ensure quality.
- Ensuring product and process documents meet established specifications through rigorous sampling and statistical process control.
- Identifying and addressing deviations from manufacturing and packaging standards.
- Approving investigations and overseeing change control activities to maintain compliance with configuration management policies.
- Contributing to project tasks and milestones, organizing work to meet deadlines.
- Learning and applying basic team effectiveness skills within the immediate work team.
- Making decisions within limited options to resolve basic problems under a supervisor's direction.
- Ensuring manufacturing and packaging records conform to Pfizer policy and cGMP standards.
- Maintaining inspection readiness, supporting regulatory and customer inspections, and improving quality assurance systems.
- Assisting manufacturing/packaging staff in real-time compliance error detection and resolution, and leading or participating in Quality Risk Management assessments.
To qualify, you will need:
- A 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.
Preferred qualifications include:
- 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 enhancement.
This role involves spending time between the office and shop floor as needed to support manufacturing. As this is a penicillin manufacturing facility, candidates must not be allergic to penicillin. The position requires a first-shift schedule (0700-1530) with occasional weekend shifts on premise.
The annual base salary for this position ranges from $68,600.00 to $114,300.00. Pfizer offers comprehensive benefits, including a 401(k) plan with matching contributions, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits.