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Senior Research Associate Job
Eingestellt von Yoh
Gesuchte Skills: Support, Sap
Projektbeschreibung
WHAT YOU'LL BE DOING:
- The primary focus will be on implementation of business processes for compliance and maintenance of compliance-related activities.
- Collaborates with team to develop and implement strategies for continuous improvement in compliance for various groups within the organization
- May perform data verification for regulatory filing sections
- The Cellular Resources department is seeking a Senior Associate to join our Regulatory and Compliance group.
- Collaborates with team to support cGxP compliance activities for the organization
- Supports nonconformance and change control records
- Collaborates with team to support site audits and inspections
- Assists in preparation and/or review of reports, presentations, and procedures
WHAT YOU NEED TO BRING TO THE TABLE:
- BS/MS degree in biological sciences or related field with a minimum of three to five (3 - 5) years of cGxP compliance and/or cGxP laboratory experience is required.
- Candidates should have demonstrated working knowledge of cGxP as it relates to biotechnology derived protein therapeutics.
- Successful candidates will possess strong communication, technical writing, and knowledge of cGxP and safety guidelines.
- Candidates must be detail oriented and able to work collaboratively in a team-based environment.
- Successful candidates will have the ability to work in a multidisciplinary environment and should display excellent organizational and communication skills.
BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:
- Previous training in a cGxP laboratory environment, involvement with audits and inspections, nonconformance, and change control are preferred.
- Experience with various data management systems, such as EDM Quality, EDM Teams, EPIC, TrackWise, and SAP is preferred.
WHAT ARE YOU WAITING FOR? APPLY NOW!
RECRUITER: Joan Lowery
Yoh, a DayJ2W: CLINICAL
MONJOBJ2WSEMW
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