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Quality Assurance Specialist

2 months ago

South San Francisco, United States Planet Pharma Full time

5 days per week onsite - South San Francisco

9 month extendable CONTRACT

$38 - $45 per hr - may have some flex for a strong applicant


Key Responsibilities

  • Supports activities for releasing or rejecting raw materials, starting materials, intermediates, drug substance, and drug products.
  • Reviews completed batch production and laboratory control records of critical process steps before disposition of drug product for clinical distribution.
  • Reviews of Quality Control analysis and results to support product release.
  • Performs quality inspection of raw materials, intermediates, packaging and labelling materials.
  • Conducts Quality on the Floor activities including, but not limited to, quality walk-throughs, change-over, drug product AQL inspection, and line clearance. Assists on changes that potentially impact intermediate, drug substance, and/or drug product quality.
  • Assists in the investigation and resolution of quality events.
  • Participates in cross-functional collaborations to meet project timelines and material/product supply requirements


Position Requirements

  • Must have 2+ years of related QA experience within the biotech, pharma or medical device industry
  • Must have strong GMP Manufacturing experience
  • Must have clean room experience
  • Must have batch records review, raw material review and inspection.
  • Excellent communication skills, both written and verbal
  • Strong organization skills and ability to effectively manage multiple priorities.