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Specialist Product Quality

Thousand Oaks, CA
Top 3 Must Have Skill Sets:        
  • change control
  • product specifications
  • quality assurance in a GMP pharmaceutical environment
  • Pharmaceutical experience required
  • Quality assurance/ Quality systems experience highly preferred
Day to Day Responsibilities:        
  • Successfully collaborate with functional groups to own and approve change records and deviations. Quality review and approve product documents such as the APR, product specifications, comparability.
Summary
Ideal candidate- B.S. in biochemistry, chemistry, biology, or a related protein or synthetic biotechnology sciences field or an equivalent level of biopharmaceutical experience with responsibility in a quality, analytical development, process development, or manufacturing environment- at least 10 years exp. Familiar with pharmaceutical sciences, quality, compliance and regulatory requirements, associated with biologics and synthetic chemical manufacturing and QC testing. Previous experience using VEEVA, Trackwise and other  quality systems. knowledge of biopharmaceutical bulk and drug product development, manufacturing, and/or Quality Control Testing

As a Product Quality (PQ) Quality Assurance (QA) Specialist, you will actively provide quality assurance support to the PQ organization as a subject matter expert of quality system records. In this team-based role you will directly add to the success of the Product Quality team by collaborating with diverse functional areas including Supply Chain, Manufacturing, Quality Control, Quality Assurance, Regulatory, Quality Engineering, International Quality and Process development on projects, issue resolution and investigations.
The QA Specialist will be encouraged to use technical abilities to lead and deliver quality assurance responsibilities while owning, reviewing, and/or approving Product Quality records and documentation including: product specifications, in-process control specifications, specification technical reports, annual product reviews (APRs), international expansion forms, change control records, appendix docs (data sheets and data analysis), Deviation Investigations/Root Cause Analysis, CAPAs, analytical comparability protocols, analytical comparability reports, and procedures.
As a team member you will be encouraged to use technical abilities to execute transactions in GMP systems (Veeva CDOCs, Trackwise, etc.) and may include additional business process support for APRs and site audits, as needed. The QA specialist may also help with guiding products through the annual product review cycles at 

Preferred Qualifications:
  • Familiar with pharmaceutical sciences, quality, compliance and regulatory requirements, associated with biologics and synthetic chemical manufacturing and QC testing.
  • B.S. in biochemistry, chemistry, biology, or a related protein or synthetic biotechnology sciences field or an equivalent level of biopharmaceutical experience with responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment.
  • Previous experience using VEEVA, Trackwise and other  quality systems.
  • Knowledge of biopharmaceutical bulk and drug product development, manufacturing, and/or Quality Control Testing
  • Strong project management skills.
  • General knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture and testing of biopharmaceuticals.
  • Previous experience working on a cross-functional team in a matrix environment.
  • Excellent written and verbal communication skills, including facilitation and presentation skills.
Basic Qualifications:
Doctorate Degree OR
Master's Degree & 3 years in Quality Assurance, Quality Control or Manufacturing OR
Bachelor's Degree & 5 years in Quality Assurance, Quality Control or Manufacturing OR
Associate's degree & 7 years in Quality Assurance, Quality Control or Manufacturing OR
High school diploma/GED & 10 years in Quality Assurance, Quality Control or Manufacturing

"This posting is for Contingent Worker, not an FTE"

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