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Quality Assurance (QA) Specialist II Job

Eingestellt von Yoh

Gesuchte Skills: Sap, Client

Projektbeschreibung

QA SPECIALIST II needed for a CONTRACT opportunity with Yoh's client located in South San Francisco, CA.

The Big Picture - Top Skills You Should Possess:
- Scan documents into our GMP document management system.
- Identify and implement process improvements, as necessary.
- Review and Interact with interdepartmental contacts on discrepancy assessment, resolution, and quality approval.

What You'll Be Doing:
- Perform final review of manufacturing batch records for Genentech manufactured cell banks and clinical large molecule drug substance, drug product and final drug product.
- Compile Batch History Records for Product Manager review.
- Provide Quality oversight to internal customers in the Manufacturing organization.
- Collaborate with departments to ensure that all review activities are executed efficiently and effectively.
- Make independent decisions around complex issues in alignment with GNE policies.

What You Need to Bring to the Table:
- BS/BA degree in the life sciences plus five to seven (5-7) years of experience.
- A minimum of at least five (5) years of experience in Quality Assurance, Quality Control, Manufacturing, or equivalent experience.
- Thorough knowledge of cGMPs (Drugs and Biologics), and regulations applicable to U.S. and international Regulatory agencies.
- Ability to interpret Quality standards for implementation
- Ability to independently evaluate situations and propose potential solutions
- Ability to interpret Quality standards for implementation
- Ability to communicate clearly and professionally both in writing and verbally
- Flexibility in problem solving and work hours to meet business objectives

Bonus Points! Otherwise Known As Preferred Qualifications:
- Knowledge of cGMPs or equivalent regulations strongly is preferred
- Knowledge of SAP and Trackwise applications and project management skills are highly desirable.

WHAT ARE YOU WAITING FOR? APPLY NOW!

RECRUITER: Rob West

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: CLINICAL

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Ref:

SFSF: LS

Projektdetails

  • Einsatzort:

    South San Francisco, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    IT Entwicklung, SAP Entwicklung

  • Skills:

    sap, client

Yoh