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Quality Assurance Biotech Packaging Associate Job
Eingestellt von Yoh
Gesuchte Skills: Support, Sap
Projektbeschreibung
THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:
- GMP Manufacturing or Quality Assurance experience
- Label and Packaging and/or Device Assembly experience
- Experience with controlled GMP documents, such as Standard Operating Procedures
WHAT YOU'LL BE DOING:
- Providing quality oversight before, during, and after ATO Drug Product Assembly and Packaging operations.
- This position has primary responsibilities for providing support of clinical packaging operations T
- Providing direct floor support of packaging processes which includes approval of labels, in-process sampling of packaged goods, issue resolution and in-process review of batch records.
- Perform final review and approval of all core and non-core batch records to ensure GMP and GDP compliance
- Ensure timely initiation, classification, closure and effectiveness evaluation of production deviation, CAPA's, and Change Control records
- Be required to work with electronic systems such as SAP, MES, Trackwise, EDMQuality and Change Control
- Tasks directly associated with the disposition of packaged lots
WHAT YOU NEED TO BRING TO THE TABLE:
- Bachelor's degree in Life Science, Chemistry, Biological Science or Biochemistry
- 2+ years of experience in quality assurance, quality control, or
- 2+ manufacturing in a biotechnology or pharmaceutical environment
- Able to evaluate documentation and operations according to company procedures
- Effectively articulates quality requirements and rationale to others in writing and verbally
- Experience in reviewing and approval of batch records, NC/CAPA's and Change Control records
- Knowledgeable of regulatory requirements/Quality Principles Able to effectively handle and operate in a rapidly changing environment
- Strong team player, Complex decision making skills
- Knowledge of clinical packaging operations a plus
WHAT'S IN IT FOR YOU?
- The Quality Assurance team offers experiences that one could not normally find outside of a Biotechnology company. These skills are highly transferable to future roles within or outside the company. Additionally, we have a very fun team that works hard and well together.
OPPORTUNITY IS CALLING, APPLY NOW!
RECRUITER: Jerome Adams
Yoh, a DayJ2W: SCIENTIFIC; MONJOB
TAX TERM: CON_W2J2WBRLA
Ref:
SFSF: LS
Projektdetails
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Einsatzort:
Thousand Oaks, 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:
SAP Entwicklung, Sonstiges