Pfizer USA Jobs – QC Instrument

Job Description:

The position will support the Pfizer Sanford, NC Quality Operations department by performing Quality Control activities associated with clinical and/or commercial product, raw materials, validation, and stability. Key responsibilities are performing GMP tasks/activities associated with maintaining compliant Quality Control; managing the GMP compliance of QC instruments/equipment; creating, reviewing, executing activates for, and approving documentation; participating in investigations of events results; acting as a change agent and driving continuous improvement/Operational Excellence/innovative implementations.

Job Responsibilities:

• Leading projects ensuring all milestones are met.
• Responsible for reporting issues to management and participating in issue resolution (such as reporting OOS results and participating in associated laboratory investigations, reporting instrument issues and assisting with troubleshooting, etc.)
• Responsible for knowing, understanding and acting in accordance with Pfizer’s values and our OWNIT culture
• Performs tasks associated with maintaining cGMP compliant Quality Control and Stability laboratories.
• Escorting vendors for routine analytical equipment maintenance; ensuring vendor training and company qualifications are up to date.
• Responsible for contributing to and/or handle laboratory investigations for events and OOS results.
• Trains junior colleagues and may develop training plans and/or oversee training activities for groups.
• Responsible for appropriate creation, review, approval and final authorization of GMP documentation (test results and records, validation protocols/reports, method transfer protocols/reports, test methods, equipment records, process transfer activities, etc.) and ensuring adherence to regulatory agency requirements, ICH guidelines, Pfizer standards, policies, and values.
• Responsible for assessing existing situations and suggesting continuous improvements to increase compliance and innovation.
• Responsible for initiating QTS records related to change management to existing analytical equipment and any new analytical equipment enrollments.

Job Requirements:

Ability to lift 30 lbs, stand for 2 to 3 hours at a time, sit for 2 to 3 hours at a time, walk long distances and bend to obtain items from lower shelving/cabinets

Qualification & Experience:

• Master’s degree and 4+ years of relevant experience
• Experience defending laboratory practices in regulatory audit.
• 7+ years of manufacturing, quality or laboratory experience in the biotech or pharmaceutical industry with a Associate Degree in Science/related field.
• Knowledgeable/experience of change control practices and quality risk management (QRM) concepts.
• 5-7 years of manufacturing, quality or laboratory experience in the biotech or pharmaceutical industry with a BS/BA Degree in Science/related field.
• 2-4 years of manufacturing, quality or laboratory experience in the biotech or pharmaceutical industry with a MS Degree in Science/related field.
• Experienced and proficient with various laboratory instrumentation/equipment and validation/qualification principles.
• Experience leading continuous improvement projects

Job Details:

Company: Pfizer

Vacancy Type: Full Time

Job Location: Durham, NC, US

Application Deadline: N/A

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