Quality Assurance Specialist

4 days ago

Exton, Pennsylvania, United States Beacon Hill Full time

Job Summary:

We are seeking a highly skilled Quality Assurance Specialist to join our team at Beacon Hill. As a Quality Assurance Specialist, you will be responsible for performing testing in support of product manufacturing, employing manual and automated analytical equipment for a variety of molecular, protein, and cell-based assays.

Key Responsibilities:

  • Execute analytical test methods for bulk intermediate testing and final product release testing.
  • Execute testing for raw materials.
  • Participate in authoring, reviewing, and revising QC SOPs and other technical documents as necessary to maintain compliance.
  • Review quality control raw data for accuracy, completeness, and compliance with effective SOPs to ensure the strength, identity, safety, purity, and quality of the product.
  • Timely response to out-of-specification results, including notification to area supervision.
  • Communicate with individual operations departments (manufacturing, quality assurance, facilities) to ensure that company objectives are met on schedule.
  • Maintain housekeeping in the laboratories.
  • Assist the quality control supervisor in daily operations, as needed.
  • Perform growth promotion testing on prepared media.
  • Direct sterile media fill trials and perform support testing.
  • Authoring and/or executing protocols and generating technical reports.
  • Analytical method validation.
  • Equipment qualification.
  • Training of other employees.
  • Completion of thorough laboratory investigation reports (LIRs) to ensure that potential problems and root causes are identified, impact assessed, and actions to prevent recurrence are considered and implemented.

Requirements:

  • Bachelor of Science degree in a relevant scientific discipline, such as biochemistry, chemistry, molecular biology.
  • Advanced degree (masters or doctorate) in a relevant scientific discipline, such as biochemistry, chemistry, molecular biology.
  • 3-5 years quality control experience in a similar role in the biologics or pharmaceutical industry.
  • 2-3 years experience in mammalian cell culture in an academic or industrial laboratory.
  • Knowledge of basic laboratory skills (including aseptic technique, etc.) are required.
  • Knowledge of current good manufacturing practice and industry standards.
  • Experience with analytical technical transfer is preferred.
  • Familiarity with analytical equipment including PCR, UV absorbance plate readers, flow cytometers, microscopes, and pH meters.
  • Experience in aseptic processing and mammalian cell culture.
  • Excellent verbal and written skills.
  • Good interpersonal communication skills.
  • Must be open to occasional off-shift and weekend work.

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