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Quality Assurance Operations - Product Inspector Job

Eingestellt von Yoh

Gesuchte Skills: Support, Engineering

Projektbeschreibung

QUALITY ASSURANCE OPERATIONS - PRODUCT INSPECTOR needed for a contract opportunity with Yoh's client located in Marietta, PA.

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- Quality Assurance
- GMP
- Deviations, CAPAs, Change controls

WHAT YOU'LL BE DOING:

- Perform technical review of cGMP documentation for completeness and compliance to cGMPs as outlined by governmental regulations and internal procedures.
- Provide advice and counsel on cGMP and related quality assurance issues to the value stream
- Demonstrate sound decision making relating to quality issues
- Provide on the floor QA support and perform QA Operations activities (batch record issuance and review, line clearance, room clearance, AQL sampling/inspection, documentation review, etc)
- Perform technical review of cGMP documentation for completeness and compliance to cGMPs as outlined by governmental regulations and internal procedures.
- Take initiative to follow-up on any issues concerned with quality documentation (eg, investigations, deviations, and other required documentation).
- Perform review and support regarding discrepancies and/or anomalies noted during QA review of associated processes. This includes deviation investigations, customer complaint investigations, etc.
- Alert management of production trends which may serve as forewarning of process or equipment problems.

WHAT YOU NEED TO BRING TO THE TABLE:

- BS/BA in Biology, Chemical Engineering, Life Sciences. Degree in other discipline if sufficient technical depth has been achieved from professional experience.
- QA and/or GMP experience.
- Working knowledge of pharmaceutical facilities, equipment and systems preferred. This includes a technical understanding of industry and science practices related to the business in order to apply knowledge to daily activities.
- Knowledge of GMP's, NIH Guidelines, FDA and other regulatory agency requirements sufficient to apply to quality operations and compliance.
- Working knowledge of validation principles, quality systems (Deviations, CAPAs, Change controls) and FDA regulations.

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Hannah Cihlar

Yoh, a DayJ2W: CLINICAL

MONJOBJ2WNECLIN

Ref:

SFSF: LS

Projektdetails

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Yoh

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