Quality Control Analyst

Position: Quality Control Analyst I
Quality Control Analyst I

Salary range:

$52,000-$67,000

Full-time, Exempt

Responsible for performing routine analytical testing of various sample types, including raw materials, intermediates, and drug substance/products to ensure compliance with GMP and regulatory standards. This analyst position is ideal for an individual transitioning into Quality Control with a baseline understanding of biologic therapeutics and cGMP. The QC Analyst I will execute established analytical methods, maintain accurate records, and uphold the highest standards of laboratory safety and data integrity.

Experience in cell-based assays and/or PCR-based analyses is preferred.

Supervisory Responsibilities

None

Duties and Responsibilities

* Perform and maintain test systems for GMP manufacturing, and performing assays related to in-production and post-production product quality. Assays in the areas of molecular, biochemical, or cell-based systems.

* Involved in reagent management, routine maintenance of laboratory equipment, and performing robust sample tracking/management.

* Document all testing activities accurately in accordance with cGMP and Good Documentation Practices (GDP).

* Support validation status of release assays, and product stability

* Participate in laboratory housekeeping, calibration, and quality initiatives.

* Work under direct supervision while learning QC systems, methods, and compliance expectations.

* Additional duties as assigned.

Education and Experience Requirements

* A Bachelor's degree in a science related field.

* Minimum of 1 year in an industry or a professional setting incorporating GDP.

Required Skills and/or Qualifications

* Familiarity with aseptic technique, basic molecular biology, or analytical methods preferred.

* Familiarity with ALCOA+ Principles of GDP, with familiarity of cGMP preferred

* 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.

* Must have demonstrated capacity to comprehend complex protocols and reports, and programs

* Must be flexible in adapting to a variety of responsibilities, work assignments, and priorities.

Physical Requirements

* Prolonged periods of standing at laboratory benches.

* Must be able to lift up to 15 pounds at times.

* 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