08 Apr
Contract Quality Control Analyst
Pennsylvania, Exton , 19341 Exton USA

Title: Contract Quality Control Analyst

Location: Exton, PA

Duration: 12+ Month contract

About the Company: A global pharmaceutical company

Benefits: Real Staffing offers medical, dental, vision, 401K, voluntary life insurance, short term/long term disability.

About the Role: The QC Analyst performs QC Biochemistry analyses of recombinant therapeutic proteins produced at the Biologics Pilot Plant. The individual executes all assay types with uniform skill, and operates most types of analytical instruments and equipment in the department following written procedures. The QC Analyst understands project priorities and schedules their own work within projects. The individual participates in assay validations and qualifications, performs biennial document reviews, and makes necessary revisions to SOPs.

Your Main Responsibilities:
  • Generate compliant laboratory data for release, assessment of stability, validation of assays, and support of process development. Perform assays and techniques involving HPLC, capillary electrophoresis, ELISA, qPCR, and/or other protein analytical technologies, executing all of the techniques used in the department with equal proficiency.
  • Participates in assay qualifications.
  • Assist with training new analysts.
  • Perform biennial SOP reviews and make needed revisions.
  • Peer-review documentation and results from other analysts for completeness.
  • Order supplies, clean equipment, organize common areas and stocks.
  • Initiate and participate in laboratory investigations.

Basic Qualifications:
  • Minimum of 3-5 years working experience in a cGMP Quality Control, analytical development, analytical transfer or validation department in a FDA-regulated industry.
  • Exhibits understanding of the principles, concepts, and practices in QC testing of biopharmaceuticals.
  • Hands-on experience in HPLC, capillary electrophoresis, ELISA, and gel-based assays for analysis of recombinant proteins.
  • Experience working under cGMP regulations and with ICH/FDA/EMA guidelines.
  • Ability to identify and investigate assay and equipment problems.
  • Physical requirements: handling of laboratory equipment, chemicals, and biological materials.
Sthree US is acting as an Employment Business in relation to this vacancy.

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