QC Analyst III, Analytical - LSA (Biomanufacturing)

Location: Portsmouth, NH, USA. Onsite laboratory schedule, Monday–Friday, 8:00 AM–5:00 PM.

Company

hirify.global operates globally connected life-science manufacturing sites focused on developing and manufacturing medicines and therapies.

What you will do

• Execute complex cGMP release and in-process testing for biological, immunological, and cell-based products.
• Perform testing using flow cytometry, ELISA, PCR assays, cell culture, and cell counting.
• Lead analytical method transfers, qualifications, validations, and onboarding of new laboratory methodologies.
• Review laboratory records, calculations, execution logs, and data for accuracy and GDP compliance.
• Lead OOS and laboratory deviation investigations, including root-cause analysis and technical reporting.
• Author and coordinate CAPAs, change controls, SOPs, master forms, and test records while training junior QC personnel.

Requirements

• 3–4+ years of direct QC laboratory experience in cGMP biomanufacturing or regulated clinical testing.
• Bachelor’s degree in Biochemistry, Biology, or a closely related technical science discipline.
• Hands-on experience with cell culture, flow cytometry immunophenotyping, PCR amplification, and immunological assays.
• Ability to independently lead laboratory investigations, develop root-cause theories, and write technical summaries.
• Experience with LIMS, enterprise data management applications, and quality systems software such as TrackWise is preferred.
• Strong written and oral communication, initiative, and ability to manage multiple testing demands.

Nice to have

• Master’s degree in a scientific discipline.
• Experience configuring advanced laboratory instrumentation and transferring analytical methods.

Culture & Benefits

• Agile career environment with a dynamic, inclusive, and ethical workplace.
• Medical, dental, and vision insurance.
• Paid time off and broader global benefits.
• Performance-focused compensation programs.
• Culture centered on collaboration, accountability, excellence, passion, and integrity.