Quality Control Associate II/III, Analytical
About The Position
The Quality Control Associate II/III, Analytical will perform analytical testing to support batch disposition, in process control, drug substance and drug product release, and stability studies. This role is central to ensuring product quality and regulatory compliance for Capricorâs cell based and exosome based therapeutic platforms. You will execute analytical assays, maintain mammalian cell cultures, document data in GMP compliant systems, support investigations, and collaborate cross functionally to ensure testing readiness and continuous improvement. This is a hands-on QC bench role within an expanding analytical team and a new headcount supporting pipeline and manufacturing scaleup.
Requirements
- Bachelorâs degree in Biological Sciences or related field.
- 2+ years of experience in a GMP QC laboratory or GMP/GLP environment.
- Handson experience with mammalian cell culture.
- Experience performing analytical assays such as ELISA, qPCR, flow cytometry, RNA sequencing, or similar technologies.
- Strong GMP documentation, data integrity, and compliant data recording skills.
- Ability to work independently, manage multiple testing assignments, and meet tight timelines.
Nice To Haves
- Experience with cell based or exosome based products.
- Experience coordinating or managing samples with outsourced/contract testing labs.
- Knowledge of method qualification or validation requirements.
- Experience writing deviations, OOS investigations, or validation protocols.
- Experience with aseptic processing and work in classified environments.
Responsibilities
- Perform QC analytical testing on in process materials, bulk drug substances, and final products to support batch release and stability programs.
- Maintain and prepare mammalian cell cultures used in potency or characterization assays.
- Conduct analytical assays such as ELISA, qPCR, flow cytometry, and RNA based methods.
- Analyze data, generate results, and enter findings into QC systems and reports.
- Document all work in accordance with GMP and data integrity standards, including batch records, lab notebooks, and controlled forms.
- Communicate test results, issues, or atypical findings to QC leadership and development partners.
- Support or author technical documentation, including deviations, OOS/OOT investigations, method qualification/validation documents, or procedural updates.
- Assist with assay troubleshooting in collaboration with Process and Analytical Development.
- Train team members on relevant lab techniques or QC procedures.
- Support updates to QC SOPs and continuous improvement initiatives.
- Manage testing priorities to meet project timelines and operational needs.
- Perform additional QC duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
11-50 employees
