QC Analyst II
4 weeks ago
The Quality Control Analyst II will play a crucial role in ensuring the quality and integrity of our products. This position will be responsible for performing routine and non-routine testing, reviewing in-process, DS, and DP release and stability samples, and executing quality systems in accordance with cGMP guidelines.
Key Responsibilities- Perform routine and non-routine testing and review of in-process, DS, and DP release and stability samples in accordance with Standard Operating Procedures (SOPs).
- Execute quality systems, including deviations, corrective and preventive actions (CAPAs), investigations, Out of Specifications (OOS), and change controls.
- Collaborate with internal and cross-functional teams to support deadlines for release and ensure timely completion of tasks.
- Participate in equipment validation, method transfer/validation, and special protocol execution.
- Generate and review protocols and reports as required.
- Bachelor's degree in Chemistry, Biochemistry, or a related science.
- Minimum 0-5+ years of laboratory experience in QC testing, preferably in a cGMP environment.
- High proficiency in q-PCR and HPLC methods and analysis.
- Strong understanding of regulations and ability to apply to any situation, identifying deficiencies with some guidance.
- Excellent communication and organizational skills, with the ability to work well with others and independently.
- Paid vacation days, amount based on tenure.
- Paid sick time.
- 9 observed holidays + 1 floating holiday + 1 volunteer day.
- 401(k) plan with company match up to 6% of salary, vested immediately.
- Share Appreciation Rights.
- Choice of several healthcare plans.
- FSA and HSA programs.
- Dental & vision care.
- Employer-paid basic term life/personal accident insurance.
- Voluntary disability, universal life/personal accident insurance.
- Accidental Death & Dismemberment (AD&D) Insurance.
Genezen is a leading provider of gene therapy solutions, committed to delivering timely treatments to patients. We operate with urgency and a commitment to scientific excellence, staying current with industry developments and making data-driven decisions. Our team is dedicated to overcoming challenges, learning from failures, and persistently striving for success.
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