Analyst II, Analytical and Quality Control

Responsibilities:

• Effectively train on and execute assigned QC testing procedures and perform new assignments with general instructions and minimal supervision.
• Support documentation for cGMP production, in-process testing, stability and release testing of cell therapy products
• Support QC functions for laboratory operations, including equipment maintenance, review and tracking of samples, testing results, materials inventory, and reagent preparation.
• Support testing execution as required for transfer of QC test methods, characterization assays and/or qualification of methods.
• Review sampling plans and support COA issuance for batch disposition
• Author or review GMP documentation for accuracy and compliance (e.g. methods, protocols, executed records) with thorough understanding of technical area of specialization.
• Report and initiate quality events and leverage technical knowledge to define solutions to moderately complex problems.
• Liaise with CROs for sample submissions and external testing results reporting.
• Other duties as required.
• Minimum Requirements:
• BSc in Life Sciences with minimum 3 years relevant experience in Cell Biology, Genetics, Biotechnology, Biochemistry or related field. MSc with minimum 1-year relevant experience preferred.
• Strong preference for experience in Quality Control and experience with Good Documentation Practices and working in a cGMP or equivalent environment.
• Experience in one or more of the following techniques is required: nucleic acid extraction, liquid handlers, qPCR, ddPCR, Pluripotent Stem cell culture, sequencing
• Experience in the following areas is highly desirable: cell therapy, pluripotent stem cells, gene editing, biotech.
• Excellent written and oral communication skills, with keen attention to detail and highly organized.
• Demonstrated flexibility in adjusting to changing priorities and schedules.
• Ability to work independently in a fast-paced, collaborative environment with a team-oriented focus.
• Weekend work on an as needed basis may be required.
• Equal Opportunity Workplace: At BlueRock, we welcome and support differences and diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.
• We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.