General Job Description
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
