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Quality Assurance Manager Job

Eingestellt von Yoh

Gesuchte Skills: Client

Projektbeschreibung

Yoh has an immediate contract opportunity for a QUALITY ASSURANCE MANAGER to join our client in Chantilly, VA. This is a contract to permanent position.

JOB OVERVIEW:

QA Manager will act as primary site representative for quality systems and ensure that all QA functions are compliant with GMP regulations and consistent with company policies and procedures in addition to conducting audits that insure continuous control over materials, facilities and products throughout the production cycle.

Job Responsibilities:
- Act as a high-level technical resource for interpretation of policy, review and approval of technical documents, and decision making for the quality unit as well as the site Quality.
- Oversee activities involved in the review and release of row material and finished product with a focus on compliance to company policies and regulatory standards.
- Provides strategy and leadership during regulatory inspections and external audits.
- Approval of Change Controls and Deviation Reports.
- Review and approve all Validation Protocols and Reports.
- Conduct GMP training for staff and ensures training is current with all required cGMP regulations.
- Coordination with various departments for setting departmental procedures and devising systems for documentation requirements.
- Managing Customer Complaints.
- Develop and manage Company Quality Management System (QMS) and quality improvement plan. Coordinate and recommend improvement initiatives and quality policy.
- Revise, review, and approve SOP's, OOS's, planned and unplanned deviations, CAPA, specifications, Batch Manufacturing Records (BMRs) and all other aspects of cGMP compliance.
- Oversee the development of validation programs (IQ/OQ/PQ)
- Develop systems for measuring compliance with the company's quality goals, objectives and standards. Recommend corrective action as required.
- Maintain Annual Product Reviews of the various products being manufactured.
- Perform Internal Quality Audits
- Monitor Non-Compliance reports and take corrective actions to assure timely completion.

Required Job Qualifications:
- B.S. degree/MS degree in a scientific discipline.
- Five (5) years of experience within pharmaceutical Quality Assurance.
- Experience in developing and executing post audit corrective action plan.

DISCOVER ALL THAT'S POSSIBLE WITH YOH. APPLY NOW.

RECRUITER: Greg Damiano

Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry; visit our website to learn both about our company and about our leading professional staffing solutions.

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

J2W: SCIENTIFIC; J2W: CLINICAL

MONJOBJ2WNECLIN

Ref:

SFSF: LS

Projektdetails

  • Einsatzort:

    Chantilly, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    IT Entwicklung

  • Skills:

    client

Yoh