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Jobs · Engineering · Massachusetts

QC Analyst - Microbiology (Temporary, 1st shift, Fri-Sun 6am-6:30pm)

Genezen · Lexington, MA · 4 days ago
On-siteEngineering$30–$45/hrTemporary

About the Company

Genezen provides process development, GMP viral vector production, and cell transduction for gene and cell therapy clinical trials. We are dedicated to empowering employees to be innovative, collaborative problem solvers in a fast-growing company where every team member contributes to success.

About the Role

The QC Analyst contractor will perform routine and non-routine QC sampling and testing of controlled environments, critical utility systems, and production processes in a GMP laboratory. This role supports a 7-day production schedule and may include in-process monitoring, utility testing, and quality management system activities such as investigations, CAPAs, and change controls.

This is a first-shift, 12-hour position (6:00 AM – 6:30 PM) on-site in Lexington, MA, with a Friday–Sunday schedule and occasional holiday support required.

Responsibilities

  • Perform QC testing of in-process and product samples while adhering to standard operating procedures (SOPs).
  • Conduct routine QC Environmental Monitoring and Microbiology sampling/testing (e.g., bioburden, endotoxin, growth promotion, Gram stain, microbial identifications) in compliance with industry regulations.
  • Write, revise, or review SOPs for quality control operations to meet regulatory requirements.
  • Support aseptic processing activities.
  • Complete documentation, perform data entry, and review in accordance with cGMP (ALCOA+ principles).
  • Maintain laboratory tasks, including housekeeping, equipment monitoring, and supply inventory.
  • Sample and test critical utility systems (e.g., water, gas) supplied to manufacturing areas.
  • Perform data trending and compile trend reports.
  • Prepare samples for shipment to contract testing laboratories and review testing data reports.
  • Investigate non-conformances, Out of Specifications (OOS), and environmental monitoring excursions.
  • Troubleshoot equipment and microbiological testing methods.
  • Train other analysts within the department.
  • Support internal and cross-functional project-related activities.

Requirements

  • Bachelor’s degree in Life Science or a related field (required).
  • 3+ years of QC Microbiology experience (required).
  • Strong understanding of laboratory practices, including aseptic technique.
  • Proficiency in cGMP/ICH/FDA/EU regulations and guidelines.
  • Experience with Microsoft Office applications (Word, Excel, PowerPoint).
  • Ability to gown aseptically.
  • Effective communication and organizational skills; ability to work independently and collaboratively.
  • Adaptability to changing work schedules, including nights, weekends, and holidays as needed.
  • Criminal background check (required; handled by staffing agency).

Physical Demands

  • Frequently required to stand, sit, use hands, reach with hands/arms, and communicate verbally and in writing.
  • Occasionally required to walk, climb, balance, stoop, kneel, or crouch.
  • Frequently lift and/or move up to 10 pounds; rarely lift and/or move up to 25 pounds.
  • Frequently utilize close vision and ability to adjust focus.

Company Values

  • Committed to Science: Pursuing scientific excellence, data-driven decisions, and innovation.
  • Urgency in Action for Patients: Accelerating treatments with a commitment to timely delivery.
  • Resilience & Grit in Operations: Overcoming challenges and learning from failures.
  • Execute with Excellence & Integrity: Delivering quality results while upholding ethical principles.
  • Solutions-Driven for Partners: Proactive, collaborative, and creative problem-solving.

Benefits

  • Paid vacation days (based on tenure).
  • Paid sick time.
  • 10 observed holidays + 2 floating holidays + 1 volunteer day.
  • 401(k) plan with company match (up to 6% of salary).
  • Share Appreciation Rights.
  • Choice of healthcare plans (medical, FSA, HSA).
  • Dental and vision care.
  • Employer-paid basic term life and personal accident insurance.
  • Voluntary disability, universal life, and AD&D insurance.

Pay

This is a temporary position filled through a third-party staffing agency. The hourly pay range is $30–$45, based on qualifications, skills, and experience.

Schedule

  • First shift: 6:00 AM – 6:30 PM, Friday–Sunday (12-hour shifts).
  • Occasional holiday support required.
  • Fully on-site in Lexington, MA.

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