Kelly
Biologics QC Associate
Job Title: Quality Control Associate II, Biologics (full benefits) Location: Bristol, Pennsylvania 19007 Job Summary: The Quality Control (QC) Associate II is responsible for routine and non-routine testing of raw materials, in-process samples, final product, and stability samples in support of GMP manufacturing. Key Responsibilities: Required skills in Analytical Techniques & Instrumentation: UPLC, HPLC, CE, cIEF, SEC, GMP Biologics analysis and testing experience Empower chromatography software LC systems with Waters instrumentation (updated from Agilent) Quality Systems & Compliance: Strong experience with quality systems, including laboratory investigations, OOS handling, peer review, and data integrity practices Troubleshooting & Method Execution: Proven ability to troubleshoot analytical methods and execute routine and non-routine testing. QC Method Lifecycle: Experience with method qualification and method validation Authorship of investigations related to analytical methods Cross-Functional Collaboration: Excellent cross-functional communication skills, including interaction with analysts and teams in a CDMO environment Qualifications & Requirements: Bachelor's degree in scientific discipline (Chemistry, Biology etc.) 3 years of QC biologics testing experience in a GMP manufacturing environment
Job Title: Quality Control Associate II, Biologics (full benefits) Location: Bristol, Pennsylvania 19007 Job Summary: The Quality Control (QC) Associate II is responsible for routine and non-routine testing of raw materials, in-process samples, final product, and stability samples in support of GMP manufacturing. Key Responsibilities: Required skills in Analytical Techniques & Instrumentation: UPLC, HPLC, CE, cIEF, SEC, GMP Biologics analysis and testing experience Empower chromatography software LC systems with Waters instrumentation (updated from Agilent) Quality Systems & Compliance: Strong experience with quality systems, including laboratory investigations, OOS handling, peer review, and data integrity practices Troubleshooting & Method Execution: Proven ability to troubleshoot analytical methods and execute routine and non-routine testing. QC Method Lifecycle: Experience with method qualification and method validation Authorship of investigations related to analytical methods Cross-Functional Collaboration: Excellent cross-functional communication skills, including interaction with analysts and teams in a CDMO environment Qualifications & Requirements: Bachelor's degree in scientific discipline (Chemistry, Biology etc.) 3 years of QC biologics testing experience in a GMP manufacturing environment