General Job Description
Responsible for performing and reviewing routine analytical testing of various sample types, including raw materials, intermediates, and drug substance/products 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 QC team is 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 Bachelor’s 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
