QA Specialist

QA Specialist
  • Competitive
    HOUR
  • Temporary
  • Berkeley CA, US Berkeley ALAMEDA US 94710
Job Ref: JO000116289
Sector: Clinical
Sub-sector: Quality
Date Added: 27 April 2021


SRG is seeking a QA Specialist for a client in Berkeley, CA.

This position is with a major pharma company, and qualified candidates should have a BS and 3+ years of related Quality Assurance experience in the biopharma industry.

Responsibilities:

  • Serve as a SME, providing technical support for clinical batch manufacturing activities
  • Review clinical batch production documentation
  • Independently review, revise and approve clinical batch production documents (e.g. master batch records, Clinical Manufacture Facility's operational SOP, Change controls, Deviations etc.)
  • Provides QA evaluation of discrepancies offering sound suggestions on improvement
  • Train internal customers/stakeholders on QAD relevant activities
  • Support internal and external inspections and audits.
  • Revise SOPs or other QA & Compliance documents.
  • Sign Certificate of Conformance (CoC) and Certificate of Analysis (CoA), if not required to be executed by an authorized person (AP).
  • Review and approve manufacturing batch records (MBRs), standard operating procedures (SOPs), sample tables (STs) and laboratory control records and associated records, specifications, sampling plan, Inspection Plan.

Qualifications:

  • BS/BA in a scientific/technical discipline
  • At least 6 years total of experience in the biopharma industry
  • 3-4+ years of quality assurance / clinical manufacturing related experience
  • Knowledge/experience with Lot Release, Quality Assurance, Quality Control, Engineering, or Manufacturing in a GMP regulated environment
  • Previous work experience in a GMP environment and exposure to manufacturing records, testing reports and SOPs

SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

SRGTalent
31/05/2021 12:00:00
USD 0.00 0.00 Hour
Contact Consultant:
Logan Kinney

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