Quality Control Analyst
About The Position
The Quality Control Analyst will engage in routine testing and project support within a fast-paced laboratory environment. Key tasks include qPCR testing of samples, requiring a collaborative team effort to ensure timely processing. The role involves both in-process testing of raw materials and finished product testing, with a focus on RNA extraction from tissue samples and analysis of pancreatin powder. Additional responsibilities include contaminant and environmental monitoring, calibration and maintenance of instruments, inventory management, and reagent preparation. Training will be provided for validation tasks such as equipment validation, lab space validation, and method drafting.
Requirements
- Experience with PCR, QC, and testing methodologies.
- Knowledge of GMP, biology, pharmaceutical, and environmental monitoring standards.
- Familiarity with FDA regulations, molecular biology, and microbiology.
- Proficiency in assay and laboratory techniques.
- Ability to handle qPCR software and instrumentation.
Nice To Haves
- Associate QC Analyst: High School Diploma or G.E.D. required; 2+ years preferred in PCR/Micro Lab experience.
- QC Analyst: 2+ years required with GMP; bachelor's degree preferred.
- Sr QC Analyst: 5+ years required with GMP; bachelor's degree preferred.
Responsibilities
- Perform routine qPCR testing with a rapid turnaround time.
- Engage in both in-process and finished product testing.
- Extract RNA from tissue samples and analyze pancreatin powder.
- Conduct contaminant and positive control environmental monitoring.
- Calibrate and maintain laboratory instruments.
- Manage inventory and prepare reagents.
- Participate in validation tasks for equipment and methods.
- Run speciation assays for sample analysis.
Benefits
- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave)
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What This Job Offers
Career Level
Entry Level
Industry
Administrative and Support Services
Education Level
High school or GED
Number of Employees
1,001-5,000 employees
