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Senior Quality Assurance Associate Job
Eingestellt von Yoh
Gesuchte Skills: Client
Projektbeschreibung
JOB RESPONSIBILITIES:
- Performing record review necessary in ensuring the compliance of manufacturing procedures to in-house specifications and government regulations on the manufacturing floor.
- Conducting reviews of manufacturing processes to ensure compliance.
- Conducting reviews of deviation/nonconformance identification and resolution.
- Participating on team to investigate deviations to determine appropriate root cause and CAPAs or may be responsible for CAPA resolution.
- Interpreting complex, explicit documentation to ensure quality standards and compliance.
JOB QUALIFICATIONS:
- Bachelor's Degree and five (5) years Quality and/or Operations experience in a CGMP Manufacturing Environment or equivalent or.
- Seven (7) years of experience in Quality and/or Operations experience in a CGMP Manufacturing Environment or equivalent.
- Knowledge of CGMP regulations for US, EU and other markets.
- Experienced with CGMP documentation review.
- Deviation and CAPA QA approval experience.
- In-depth understanding of Environmental Monitoring and Critical Utilities.
- Understanding of lab investigation and handing of OOS results.
- Industry bio-pharmaceutical experience.
- Participated on project teams.
- Practical experience with leading deviation/nonconformance identification and resolution.
- Trackwise system experienced.
DISCOVER ALL THAT'S POSSIBLE WITH YOH. APPLY NOW.
RECRUITER: Natane Peslis
Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry.
Yoh, a Day and Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.
J2W: CLINICAL
MONJOBJ2WMIDATL
Ref:
SFSF: LS
Projektdetails
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Einsatzort:
Cambridge, Vereinigte Staaten
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
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Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung