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Quality Assurance Coordinator Job
Eingestellt von Yoh
Gesuchte Skills: Support, Engineering
Projektbeschreibung
THE BIG PICTURE - TOP SKILLS SHOULD YOU POSSESS:
- Quality
- cGMP
- Regulatory
WHAT YOU'LL BE DOING:
- Collect and evaluate information to assist in internal and vendor audits, may support or conduct internal audits and prepare summary reports.
- Manage vendor lists.
- Review production and control records using established procedures and guidelines to support lot release of raw materials, components, and finished goods.
- Administer electronic systems using established procedures and guidelines to support lot release of raw materials, components and finished goods.
- Support special projects such as validation, site priority, or new products as required.
- Supports and/or assures completion of annual product reviews.
- Assist in data collection and preparation of trend analysis reports.
- Review for abnormal trends or indications of major problems.
- Advanced knowledge in cGMP, CFR and other regulations in order to assure quality compliance.
- Performs review of documents related to change management such as work order review.
- Assist in organizing and conducting training sessions.
- Assist junior staff with problem solving.
- Perform review of technical documents such as for equipment and process validation, automation and computer validation.
- Manages or supports closure quality system records including investigations, corrective and preventative actions, and change control.
- Update departmental documents such as SOPs as required.
- Attend meetings as a quality representative and provide input as required.
WHAT YOU NEED TO BRING TO THE TABLE:
- BS or BA in Biology, Chemistry, Engineering, Biochemistry, Computer Science, Computer Engineering, or related field.
- Sufficient technical depth or professional experience will be considered in lieu of technical degree.
- Minimum one (1) year industrial experience in quality organizations, either in operations or assurance functions.
- The position requires knowledge of cGMP in the regulated industry of pharmaceutical production and supply.
BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:
- Knowledge of NIH Guidelines, FDA, and other regulatory agency requirements
OPPORTUNITY IS CALLING, APPLY NOW!
RECRUITER: Hannah Cihlar
Yoh, a DayCLINICAL
MONJOBJ2WMIDATL
Ref:
SFSF: LS
Projektdetails
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Einsatzort:
King Of Prussia, Russische Föderation
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
-
Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Sonstiges