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QC Analyst I

1 month ago

Lexington, Kentucky, United States Genezen Full time
Job Summary

The Quality Control Analyst I will be responsible for performing routine and non-routine testing according to Standard Operating Procedures (SOPs) at Genezen's state-of-the-art facility in Lexington, MA. This role supports the operations within the Quality Control group via execution of analytical testing and Quality Systems.

Key Responsibilities:

  • Perform routine/non-routine testing and review of in-process, DS and DP release and stability samples in accordance with Standard Operating Procedures (q-PCR, HPLC, Osmolality, Western Blot, etc.)
  • Performs peer review with minimal errors.
  • Able to work effectively in internal/cross-functional teams as an active member. Train and execute on assays cross-functionally to support deadlines for release.
  • Participate in equipment validation, method transfer/validation, and special protocol execution

Requirements:

  • Adaptability required as work schedule may change based on business needs
  • Criminal background check required
  • Other duties as assigned

Preferred Qualifications:

  • BA or BS in Chemistry/Biochemistry or other related science
  • Minimum 0-3 years of laboratory base experience within QC testing capacity, preferably in cGMP environment.
  • Proficiency in q-PCR and HPLC methods and analysis
  • Follow procedures trained on and complete documentation applying cGMP/GDP/ALCOA+
  • Understanding of industry testing requirements/standards
  • Computer literacy (MS Word, Excel, and LIMS)
  • Good/effective communication and organizational skills with the ability to work well with others and independently

Genezen's Benefits:

  • 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

About Genezen:

Genezen is a leading provider of gene therapy solutions, committed to delivering high-quality products and services to our clients. We operate two locations: one in Fishers, Indiana, and the second in Lexington, Massachusetts. Our team is dedicated to making a difference in the lives of patients and families affected by genetic diseases.