QC-Associate II, Analytical

Ascend Advanced Therapies FL, Inc. • Alachua, FL

13h

About The Position

The Analytical Quality Control Associate II performs routine and non-routine in-process, release, and stability testing of drug substance and drug product samples using analytical methods. The role supports method qualification, validation, and transfer in alignment with ICH guidelines, collaborates with cross-functional stakeholders, and supports external analytical testing activities under general supervision.

The position also helps maintain laboratory readiness, documentation, sample and inventory tracking, and preparation for audits and regulatory inspections. The job description may change at any time.

Requirements

• Bachelor’s degree in Chemistry, Biochemistry, Biology, or a related scientific discipline, or a master’s degree in a relevant discipline.
• Minimum of 2–4 years of analytical QC testing experience in a cGMP/GLP environment, or 0–2 years with an advanced degree.
• Hands-on experience with analytical separation and quantitative techniques such as HPLC/UPLC, capillary electrophoresis, spectrophotometry, or quantitative molecular assays.
• Familiarity with ICH guidelines, including Q2 analytical validation, and pharmacopeial standards such as USP and Ph. Eur.
• Basic understanding of quality systems, including deviations, change controls, and OOS workflows.
• Strong written and verbal communication skills, attention to detail, and data integrity.
• Proficiency in Microsoft Office Suite and chromatography data systems such as Empower or ChemStation, or LIMS.

Nice To Haves

• Experience in the biotechnology or pharmaceutical industry is preferred.

Responsibilities

• Perform routine and non-routine in-process, release, and stability analytical testing using methods such as HPLC/UPLC, CE-SDS, cIEF, UV-Vis, qPCR, ddPCR, or ELISA.
• Support transfer of qualified and validated analytical methods from contract testing laboratories to the in-house GMP laboratory.
• Analyze data and participate in peer review of laboratory testing data, assay run sheets, and notebooks for release and stability studies.
• Draft and revise analytical SOPs, test methods, forms, and Certificates of Analysis.
• Initiate and support laboratory investigations, OOS/OOT investigations, deviations, and CAPAs under senior staff guidance.
• Prepare reagents, order testing supplies, monitor calibration schedules, and document instrument usage in GMP logbooks.
• Help coordinate sample shipments and track assay timelines with external contract laboratories.
• Support internal audits and regulatory inspections by retrieving documentation and maintaining bench-level inspection readiness.
• Assist with inventory management, reference standard tracking, and stability sample pulling.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level