Analysis Skills, Asepsis, Assays, Biochemistry, Calibration, Current Good Manufacturing Practice (cGMP), Data Quality, Detail Oriented, Drug Products, Equipment Maintenance/Repair, GMP (Good Manufacturing Practices), Health Plan, Housekeeping/Cleaning, Laboratory Equipment, Maintain Compliance, Manufacturing Systems, Molecular Biology, Physical Demands, Polymerase Chain Reaction (PCR), Production Schedule, Quality Assurance, Quality Control, Record Keeping, Regulatory Compliance, Safety Standards, Systems Maintenance, Testing
Quality Control Analyst
Salary range: 52000-67000
Full-time, Exempt
Responsible for performing routine analytical testing of various sample types including raw materials, intermediates, and drug substance/product 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 Bachelors 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.