Quality Control Analyst

Quality Control Analyst II

Location: [Location]

Salary: $59,000 - $76,500

Employment Type: Full-Time | Exempt

Relocation Support: Available

About the Role

We're looking for a Quality Control Analyst II to join a growing Quality Control team supporting the development and manufacture of advanced biologic and cell therapy products. This role is responsible for performing and reviewing analytical testing of raw materials, intermediates, and drug substances/products to ensure compliance with GMP standards and product specifications.

The successful candidate will work both independently and collaboratively to troubleshoot analytical methods, support method qualifications, contribute to laboratory investigations, and help drive continuous improvement initiatives within the QC function.

Key Responsibilities

• Perform routine analytical testing on raw materials, intermediates, and drug substances/products in accordance with GMP requirements.
• Execute, troubleshoot, and optimize analytical methods including:
• Potency assays
• qPCR/dPCR
• ELISA
• Flow cytometry
• Review, interpret, and verify analytical data to ensure accuracy, traceability, and regulatory compliance.
• Support method qualification, stability studies, and sample management activities.
• Participate in Out of Specification (OOS), Out of Trend (OOT), deviation, and CAPA investigations.
• Assist with the preparation of protocols, reports, SOPs, and other GMP documentation.
• Train and mentor junior laboratory personnel as needed.
• Maintain laboratory readiness for internal and external audits.
• Contribute to process improvements that enhance laboratory efficiency and quality.
• Support additional QC activities as required.

Required Qualifications

• Bachelor's degree in Biology, Chemistry, Biochemistry, Molecular Biology, or another relevant scientific discipline.
• 2-5 years of industry experience within biologics, vaccines, cell therapy, gene therapy, or another GMP-regulated environment.
• Experience working within a Quality Management System (QMS).

Preferred Technical Experience

Experience with one or more of the following:

• Aseptic laboratory techniques
• Molecular biology assays
• Cell-based potency assays
• Protein or biochemical assays
• qPCR and/or dPCR
• ELISA
• Flow cytometry
• LIMS and Electronic Laboratory Notebooks (ELN)
• GMP documentation and data integrity requirements

What We're Looking For

• Strong analytical and problem-solving skills.
• Excellent attention to detail and documentation practices.
• Ability to work independently while collaborating effectively within a cross-functional team.
• Strong organisational skills with the ability to manage multiple priorities.
• Experience writing technical protocols, reports, and quality documentation.
• A proactive mindset with a commitment to continuous improvement.

Working Environment

• Laboratory and office-based role.
• Prolonged periods of sitting and computer work are required.
• Occasional evening or weekend work may be required to support production schedules and operational needs.

Benefits

• Competitive healthcare package, including medical, dental, and vision coverage.
• Company-paid life insurance and short- and long-term disability.
• Retirement savings plan with employer match.
• Educational assistance program.
• Generous paid time off and company holidays.
• Relocation support available for qualified candidates.

Equal Opportunity Employer

Our client is an Equal Opportunity Employer and is committed to fostering an inclusive workplace. Employment decisions are made without regard to race, colour, religion, sex, national origin, age, disability, genetic information, gender identity, sexual orientation, veteran status, marital status, or any other protected characteristic under applicable law.