QC Analyst II
4 weeks ago
The Quality Control Specialist II will be responsible for performing routine and non-routine quality control testing according to established Standard Operating Procedures (SOPs). This position is based at Genezen's state-of-the-art facility in Lexington, MA, and supports the evening and occasional weekend operations within the Quality Control group.
Key Responsibilities- Perform routine and non-routine quality control testing, including in-process testing, lot release testing, and stability testing, in accordance with SOPs and cGMP guidelines.
- Review and analyze test results, identifying any deviations or out-of-specification (OOS) results, and implement corrective actions as necessary.
- Participate in equipment validation, method transfer/validation, and special protocol execution.
- Generate and review protocols and reports, as required.
- Collaborate with cross-functional teams to ensure timely completion of testing and implementation of quality systems.
- Bachelor's degree in Chemistry, Biochemistry, or a related science.
- Minimum 0-5+ years of laboratory experience in a QC testing capacity, 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, with minimal guidance.
- Experience with LIMS and other laboratory software.
- Strong communication and organizational skills, with the ability to work effectively in a team environment.
- Paid vacation days, sick time, and holidays.
- 401(k) plan with company match.
- Share Appreciation Rights.
- Choice of healthcare plans.
- FSA and HSA programs.
- Dental and vision care.
- Employer-paid basic term life/personal accident insurance.
- Voluntary disability, universal life/personal accident insurance.
- Accidental Death & Dismemberment (AD&D) Insurance.
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