Analysis Skills, Asepsis, Assay Methods, Assays, Biochemistry, Cell Biology, Continuous Improvement, Corrective and Preventative Action (CAPA) Systems, Data Quality, Detail Oriented, Digital Polymerase Chain Reaction (Digital PCR), Drug Products, GMP (Good Manufacturing Practices), Gene Therapy, Health Plan, Identify Issues, Laboratory Information Management System (LIMS), Maintain Compliance, Molecular Biology, Operational Support, Physical Demands, Production Schedule, Quality Control, Real-time PCR (qPCR), Regulatory Compliance, Specimens/Samples, Support Documentation, Testing, Traceability, Vaccination
Quality Control Analyst II
Salary range: 59000 - 76500
Full-time, Exempt
Responsible for performing and reviewing routine analytical testing of various sample types including raw materials, intermediates, and drug substance/product to ensure compliance with GMP standards and product specifications. This QC Analyst II position requires team-coordinated work combined with exercising more independent efforts to troubleshoot methods, support method qualifications, and investigations pertaining to OOS/OOT findings. Increased efforts in document writing and supporting operational aspects of the QC team are an important function of this position.
Supervisory Responsibilities: None
Duties and Responsibilities:
- Execute and troubleshoot analytical methods including potency assays (qPCR, dPCR, ELISA, and/or flow cytometry).
- Review and interpret analytical data ensuring accuracy, traceability, and compliance.
- Assist in method qualification, sample management, and stability testing.
- Support OOS/OOT investigations, deviations, and CAPA implementation.
- Train junior analysts and maintain laboratory readiness for audits.
- Contribute to continuous improvement and process efficiency projects.
- Additional duties as assigned.
Education and Experience Requirements:
- A Bachelors degree in a science-related field.
- 2-5 years of industry experience in biologics, vaccines, cell & gene therapy, or a similarly relevant area utilizing a defined QMS.
Required Skills and/or Qualifications:
- Well versed in aseptic technique, molecular biology assays, cell-based potency assay, and/or biochemical/protein assays.
- Familiarity with data integrity principles and electronic systems (LIMS, ELN).
- Should be detail-oriented and have the ability to work independently and productively under general direction, routinely exercise initiative and sound judgment to contribute to team objectives.
- Able to assist in the authorship of complex protocols and reports and/or quality programs.
- Must be flexible in adapting to a variety of responsibilities, work assignments, and priorities.
Physical Requirements:
- Prolonged periods of sitting at a desk and working on a computer.
- Job Type: Weekends or weeknight work is occasionally required depending on the production schedule or process needs.
Benefits:
- Group Healthcare Plan including company paid dental and vision.
- Short- and long-term disability, life, and AD&G insurance.
- Simple IRA with employer match.
- Educational assistance program.
- Holiday and PTO.