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QC Analyst II

2 months ago

Lexington, Kentucky, United States Genezen Full time
Job Summary

Genezen is seeking a highly skilled QC Analyst II to join our team in Lexington, MA. As a key member of our Quality Control group, you will be responsible for performing routine and non-routine QC testing according to Standard Operating Procedures (SOPs). This role requires a strong understanding of cGMP guidelines and the ability to work effectively in internal and cross-functional teams.

Key Responsibilities
  • Perform routine and non-routine testing and review of in-process, DS, and DP release and stability samples in accordance with SOPs.
  • Develop and implement quality systems, including deviations, CAPAs, investigations, OOS, and change controls.
  • Collaborate with cross-functional teams to ensure timely release of products and compliance with regulatory requirements.
  • Participate in equipment validation, method transfer/validation, and special protocol execution.
  • Generate and review protocols and reports as required.
Requirements
  • Bachelor's degree in Chemistry, Biochemistry, or 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 industry testing requirements and standards.
  • Excellent communication and organizational skills.
Benefits
  • Paid vacation days and sick time.
  • 9 observed holidays, 1 floating holiday, and 1 volunteer day.
  • 401(k) plan with company match up to 6% of salary.
  • Share Appreciation Rights.
  • Choice of several 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.