Sr. Laboratory Specialist
About The Position
At Pfizer, we believe that every role contributes to our mission of improving patients' lives. Whether you are involved in the design and development of manufacturing processes for products or supporting the upkeep of systems, engineering is crucial to ensuring customers and patients receive the medicines they need. By collaborating with our forward-thinking engineering team, you'll play a pivotal role in accelerating the delivery of medicines to the world. In this role, you will: Perform testing (physical, functional, visual, etc.) on medical devices and combination products (MDCPs) using moderate to highly complex laboratory instrumentation with minimum supervision. Maintain data integrity and ensure compliance with company SOPs, GLP and cGMP regulations. Train, guide and mentor laboratory technicians, fostering skill development and compliance with best practices. Provide technical expertise to troubleshoot and resolve equipment and testing issues, ensuring operational readiness. Author and review technical documents, including standard operating procedures (SOPs), work instructions, etc. Lead laboratory investigations related to deviations, out-of-specification (OOS) results and equipment issues. Collaborate with Quality and Engineering teams to ensure timely closure of investigations. Support Test Method development, validation and transfer activities. Serve as SME for current laboratory test method capabilities, support test method introduction, and refinement activities. Ensure that instrumentation/equipment are properly maintained and calibrated. Support timely resolution of calibration alerts. Drive improvements in laboratory efficiency, safety and compliance. Support the identification and implementation of new technologies, techniques and best practices.
Requirements
- Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with 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
- Experience operating and maintaining device and/or packaging equipment.
- Knowledge of electronic Laboratory Notebooks (eLNs).
- Experience working within a regulated environment.
- Good communication (oral and written) and interpersonal skills.
- Critical thinking/problem solving skills.
- An ability to work independently as well as a member of a team in a fast-paced environment.
- Working knowledge of Excel, Word, etc.
Nice To Haves
- Relevant pharmaceutical experience
- Understanding of regional pharmaceutical compendia testing requirements
- Excellent communication and interpersonal skills
- Strong organizational skills and attention to detail
- Demonstrated leadership capabilities and mentoring skills
Responsibilities
- Perform testing (physical, functional, visual, etc.) on medical devices and combination products (MDCPs) using moderate to highly complex laboratory instrumentation with minimum supervision.
- Maintain data integrity and ensure compliance with company SOPs, GLP and cGMP regulations.
- Train, guide and mentor laboratory technicians, fostering skill development and compliance with best practices.
- Provide technical expertise to troubleshoot and resolve equipment and testing issues, ensuring operational readiness.
- Author and review technical documents, including standard operating procedures (SOPs), work instructions, etc.
- Lead laboratory investigations related to deviations, out-of-specification (OOS) results and equipment issues.
- Collaborate with Quality and Engineering teams to ensure timely closure of investigations.
- Support Test Method development, validation and transfer activities.
- Serve as SME for current laboratory test method capabilities, support test method introduction, and refinement activities.
- Ensure that instrumentation/equipment are properly maintained and calibrated.
- Support timely resolution of calibration alerts.
- Drive improvements in laboratory efficiency, safety and compliance.
- Support the identification and implementation of new technologies, techniques and best practices.
Benefits
- 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
- health benefits to include medical, prescription drug, dental and vision coverage
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
