Associate, Quality Control

Department
Quality Control

Location
San Diego

Summary Description
The QC Associate is a key member of the Quality Control department and reports directly to the QC Associate Director. The QC Associate is responsible for conducting analysis of materials required for the production, release, and stability of finished drug product within standard operating procedures following GLP and GMP guidelines.

The QC Associate will perform release, stability, and in-process testing of raw materials, in process samples, and final products. They will assist with the analysis and interpretation of test results, identify deviations, and make appropriate recommendations.

Responsibilities:

  • Perform in-process and release testing of bulk drug substance, lyophilized powder, and drug product.
  • Perform raw material testing for release.
  • Performs all required QC tests such as Moisture Content, Viable Cell Count, Appearance, Visual Control, and Package Integrity.
  • Provides back-up assistance for other QC systems such as the Environmental program.
  • Compiles and reviews data for documentation of test procedures and prepares reports.
  • Perform investigations for out of specification or limits occurrences and deviations.
  • Determine preventative and corrective actions for laboratory investigations.
  • Write and revise standard operating procedures and other related GLP/GMP documentation.
  • Performing peer and technical review of laboratory data.
  • Evaluate trend data and author trend reports to proactively identify adverse trends.
  • Keep accurate and complete records per cGMP.
  • Other duties and special projects as may be assigned.

Qualification Requirements:

  • A relevant scientific degree with a minimum of 3 years’ experience in a GMP environment.
  • Experience in cGMP QC laboratory setting.
  • Knowledge of cGMP and regulatory requirements pertaining to biotechnology and pharmaceutical industries.
  • Possess a strong work ethic along with a solid organizational, time management, problem-solving, decision-making, judgment, and interpersonal skills.
  • Demonstrated experience working independently, quickly, and flexibly with testing schedules.
  • Demonstrated experience analyzing critical data and proactively solving problems.
  • Proven collaboration skills, learning agility, conceptual and strategic thinking, passion for results, and ability to navigate ambiguity
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