QC Analyst I

1 day ago


Lexington, Kentucky, United States Genezen Full time
Job Title: QC Analyst I

Job Summary:

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

Key Responsibilities:

  • Perform routine and non-routine testing and review of in-process, DS, and DP release and stability samples in accordance with SOPs.
  • Peer review with minimal errors.
  • Work effectively in internal and 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.

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 fast-growing company dedicated to empowering its employees to be their best and making Genezen a rewarding place to work. We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.

Location:

Genezen operates two locations: one in Fishers, Indiana, and the second in Lexington, Massachusetts. Fishers is a suburb of Indianapolis, known for its livability, safety, and entrepreneurship. Lexington, Massachusetts, is renowned as a historic suburb with a rich cultural heritage, boasting picturesque New England charm, tree-lined streets, and a vibrant community.


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