QC-Associate II, Analytical

Job Overview
The Analytical Quality Control Associate II is responsible for performing routine in-process, release, and stability testing for drug substance and drug product samples using analytical methods. The candidate will support and participate in method qualification, validation, and transfer activities in alignment with ICH guidelines. Additionally, the incumbent will collaborate with cross-functional stakeholders and support external analytical testing activities under general supervision.

Key Responsibilities:

• Perform routine and non-routine in-process, release, and stability analytical testing (e.g., HPLC/UPLC, CE-SDS, cIEF, UV-Vis, qPCR, ddPCR, or ELISA).
• Support the transfer of qualified and validated analytical methods from contract testing laboratories (CTLs) to the in-house GMP laboratory.
• Perform data analysis and participate in the peer-review of laboratory testing data, assay run sheets, and notebooks for release and stability studies.
• Draft and revise analytical Standard Operating Procedures (SOPs), test methods, forms, and Certificates of Analysis (CoAs).
• Initiate and support laboratory investigations, out-of-specification (OOS)/out-of-trend (OOT) investigations, deviations, and CAPAs under senior staff guidance.
• Maintain laboratory readiness by preparing reagents, ordering testing supplies, monitoring calibration schedules, and documenting instrument usage in GMP logbooks.
• Assist in coordinating sample shipments and tracking assay timelines with external contract laboratories.
• Support preparation for internal audits and regulatory inspections by retrieving documentation and ensuring bench-level inspection readiness.
• Assist in routine inventory management, reference standard tracking, and stability sample pulling.
• It should be noted that this job description is subject to change at any time.

Educational Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Biology, or a related scientific discipline (or Master's degree in a relevant discipline).

Additional Qualifications

• Minimum of 2–4 years of analytical QC testing experience in a cGMP/GLP environment (or 0–2 years with an advanced degree), preferably within the biotechnology or pharmaceutical industry.
• Hands-on experience with core analytical separation and quantitative techniques (e.g., HPLC/UPLC, capillary electrophoresis, spectrophotometry, or quantitative molecular assays).
• Familiarity with ICH guidelines (Q2 analytical validation) and pharmacopeial standards (USP, Ph. Eur.).
• Basic understanding of quality systems (deviations, change controls, OOS workflows).
• Strong written and verbal communication skills with high attention to detail and data integrity.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and chromatography data systems (e.g., Empower, ChemStation) or LIMS.