Quality Control Analyst II

Quality Control Analyst II

Salary range:

$59,000 - $76,500

Full-time, Exempt

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