Quality Control Analyst II

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.