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QA Specialist II Job
Eingestellt von Yoh
Gesuchte Skills: Support, Engineering
Projektbeschreibung
THE BIG PICTURE - TOP SKILLS SHOULD YOU POSSESS:
- Quality Assurance
- cGMP
- Manufacturing
WHAT YOU'LL BE DOING:
- Support the release of manufactured materials such as intermediates and bulk products
- Support the development and maintenance of quality procedures, and systems related to Quality Assurance oversight
- Provide technical support for the US FCC site in all cGMP compliance related matters, including assurance that all aspects comply with cGMPs, legal, regulatory requirements, and the Quality Manual requirements
- Releases intermediates and bulk products using the SAP system
- Ensures all aspects of USFCC operations comply with the requirements of the Quality manual and meets all relevant cGMP regulatory requirements
- Supports the development of quality systems for QA oversight of manufacturing processes, in-process sampling and control, quality systems and QA compliance
- Supports the development and implementation of standard operating procedures (SOPs) and supplemental documents governing management and usage of each quality system of responsibility
- Acquires and maintains knowledge of current local and international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality/compliance related matters are provided to the site
- Participates as the QA representative on multi-functional continuous improvement (lean, six sigma, issue resolution, etc.) teams, as applicable
- Hands on field execution and data collection, and assist with analysis and review of data
- Execute quality review and approval of GMP documentation such as batch records
- Perform assigned tasks as needed to support quality operations
WHAT YOU NEED TO BRING TO THE TABLE:
- Bachelor's degree in Science/Engineering discipline preferred or equivalent experience in biotech or pharmaceutical industry
- Three or more (3+) years' experience in Quality Assurance and/or in a GMP regulated environment with the pharmaceutical industry or equivalent
BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:
- Sterile product manufacturing knowledge preferred
- Biopharmaceutical experience a plus
- Experience with LIMS a plus
OPPORTUNITY IS CALLING, APPLY NOW!
RECRUITER: Hannah Cihlar
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Ref:
SFSF: LS
Projektdetails
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Einsatzort:
Holly Springs, Vereinigte Staaten
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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