QC Analyst II

4 weeks ago


Lexington, Massachusetts, United States Genezen Full time
Job Summary

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.
Requirements
  • 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.
Preferred Qualifications
  • Experience with LIMS and other laboratory software.
  • Strong communication and organizational skills, with the ability to work effectively in a team environment.
Genezen's Benefits
  • 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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