02 Sep
QA Specialist IV
Massachusetts, Swansea , 02777 Swansea USA

Vacancy expired!

QA Specialist IV

  • On-site
  • Swansea, MA area
  • Support Phase I/II Clinical Manufacturing Campaigns and Clinical Shipments

  • Perform data and document review for Batch Records, Solution Records, Test Records, Stability and Validation documents
  • Perform review of INDs for submission
  • Write, review, and approve SOPs, batch records, material specs and test record
  • Conduct audits (Internal, Vendors, Suppliers, Sub-Contractors Testing Facilities, and Clinical)
  • Review and approve Quality System documentation
  • Trend and report QA related information (Deviations, CAPAs, EM excursions, Non-conformances, Change Controls etc.)
  • Assist with disposition of Clinical Product and Cell Banks

  • Oversee Environmental Monitoring Alert/Action Program
  • Support the stability program through review of protocols, reports, and data
  • Confirm Clinical Site Essential Documents are in place for initial drug supply shipments
  • Perform PCO and Area Clearance responsibilities for MFG and MM processes
  • Review and approve protocols including Manufacturing, Test Method, Equipment (IQ, OQ, and Process Validation, Cleaning Validation) etc.
  • Review method and process reports for compliance
  • Raw material review and disposition
  • MS review and approval

  • Assignment of equipment numbers and review of Calibration certificates and OOTs
Required Education/Experience:
  • Bachelor Science degree in Chemistry/Biology or related discipline
  • 6+ years QA experience in Biotech/Pharma industry or combination of QA/MFG or QC experience
  • Strong understanding of QC test methods, stability procedures and environmental monitoring programs

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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