Senior QC Scientist

3 weeks ago

Exton, United States Beacon Hill Full time

eneral Responsibilities:

Performs testing in support of product manufacturing, employing manual and automated analytical equipment for a variety of molecular, protein and cell based assays, such as PCR, ELISA, and flow cytometry.

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 of 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 (OOS) results, including notification to area supervision.
  • Communicate with the 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.

Computer Skills:

  • To perform this job successfully, an individual should have knowledge of Database software; Project Management software; Spreadsheet software and Word Processing software.

Education:

  • 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

Experience:

  • 8-10 years Quality Control experience in a similar role in the biologics or pharmaceutical industry
  • 6-8 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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