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Senior Associate QA Job
Eingestellt von Yoh
Gesuchte Skills: Support, Sap
Projektbeschreibung
THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:
- GMP databases
- experience working in SAP, Trackwise and EDMQ
WHAT YOU'LL BE DOING:
- Primar Provide Quality Assurance oversight for global distribution and supply chain operations for commercial and clinical biopharmaceutical products.
- Ensure compliance to GMP regulations for area operations and associated processes.
- Support investigations/deviation reports related to temperature excursions
- Provide support as needed within the Distribution & Supply Chain quality assurance group
- This position requires effective communication, ability to work well in teams, demonstrated science based approach and ability to deliver results.
- The successful candidate will have experience working in multiple GMP databases.
WHAT YOU NEED TO BRING TO THE TABLE:
- Bachelor's degree in Life Science, Chemistry, Biological Science or Biochemistry or equivalent.
- Two (2+) years of experience in quality assurance, quality control, or
- Two (2+) manufacturing in a biotechnology or pharmaceutical environment
- Demonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and good documentation practices.
- Educated in a science field with five (5) years of experience in GMP/GCP operations or similarly regulated industry
- Demonstrated ability to use computer databases for query of data, managing status, and input of data and documentation
- Ability to focus on detail and ensure accuracy of execution tasks, documentation per GMP standards
- Effective verbal and written communication skills, strong interpersonal skills
- Ability to complete tasks autonomously, provide updates to area manager, and identify potential issues
BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:
- Three (3+) years of experience in quality assurance, quality control, or 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
- Knowledgeable of regulatory requirements/Quality Principles
- Strong technical writing skills, demonstrated experience conducting thorough investigations and creating deviation technical assessments or equivalent
- Able to effectively handle and operate in a rapidly changing environment
- Strong team player
- Complex decision making skills
- Previous experience working in SAP, Trackwise and EDMQ
RECRUITER:Mary Nguyen
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.
J2W: SCIENTIFIC
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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