Senior Quality Control Specialist

4 weeks ago

Newark, Delaware, United States TalentBurst Full time
Job Summary

The QC Analyst II will be responsible for testing in-process, lot release, and stability samples for commercial and clinical drug products. This role involves authoring and revising SOPs, deviations, CRs, and LIRs, as well as participating in investigations, reports, and process optimization activities.

Key Responsibilities
  • Perform routine and non-routine release, in-process, and stability testing for drug substance, drug product, and other critical reagents and documentation under cGMP.
  • Conduct analytical assays such as HPLC, ELISA, SDS-PAGE, Western Blot, Water Content, UV, Appearance, and pH.
  • Independently author and lead quality records such as Deviations, Lab Investigations, CAPA, Change Control, and lead thorough and timely investigation and/or implementation activities.
  • Author and revise SOPs as needed.
  • Lead and/or support method development, optimization, transfer, qualification, and validation activities of analytical methods.
  • Support equipment and software qualification and maintenance activities.
  • Review laboratory records generated in support of QC testing, including procedures, methods, audit trails, and other controlled documents.
  • Provide training to laboratory analysts as needed and guide junior analysts in the lab environment, including troubleshooting.
  • Work on multiple projects to meet departmental and organization goals.
  • Collaborate with Manufacturing, QA, and Regulatory to support CMC analytical deliverables.
Requirements
  • 3-4 years of experience in a Quality Control laboratory environment (GMP environment) with a commercial setting.
  • Hands-on experience with a wide range of analytical techniques such as ELISA, SDS-PAGE, Western Blot, Karl Fisher, and HPLC.
  • Writing and/or authoring deviations, lab investigations, protocols, SOPs, reports, and data trending.
  • Prior experience working in method validations, method transfers, raw material, and stability testing is a plus.
  • Must be able to maintain data integrity and understanding of US and international (e.g., EU, ICH, GXP) regulations.
  • Ability to manage multiple tasks and meet deadlines with a high tolerance for ambiguity, solutions-oriented, and able to problem-solve and identify root cause.
Education
  • BS in Biology, Chemistry, or related Sciences.
  • Preferably in the pharmaceutical industry with knowledge of cGMPs is desired.

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