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Quality Assurance Specialist Job

Eingestellt von Yoh

Gesuchte Skills: Support, Engineering

Projektbeschreibung

QUALITY ASSURANCE SPECIALIST needed for a CONTRACT opportunity with Yoh's client located in Marietta, PA.

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- Quality Assurance
- GMP

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, et al.
- 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.
- Including 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.

BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:

- Working knowledge of pharmaceutical facilities, equipment and systems is preferred.

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Hannah Cihlar

Yoh, a DayJ2W: SCIENTIFIC; J2W: ENG

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Ref:

SFSF: LS

Projektdetails

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Yoh