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

The role

The QC Analyst will perform routine and non-routine QC sampling and testing of controlled environments, utility systems, and production processes in a GMP laboratory. This role supports environmental monitoring, utility monitoring, and quality management systems.

What you will do

• Perform QC testing of in-process and product samples adhering to SOPs
• Ensure routine QC Environmental Monitoring and Microbiology sampling and testing
• Write, revise, or review SOPs for quality control operations
• Support aseptic processing activities
• Complete documentation and data entry in accordance with cGMP and ALCOA+
• Perform laboratory tasks including housekeeping, equipment monitoring, and inventory
• Sample and test critical utility systems including water and gas
• Perform data trending and aid in compilation of trend reports
• Prepare samples for shipment to contract testing laboratories
• Conduct non-conformance, OOS, and environmental monitoring excursion investigations

Required qualifications

• Bachelor’s degree in Life Science or related science
• 3+ Years of QC Microbiology Experience
• Strong understanding of required laboratory practices including aseptic technique
• Well versed in cGMP/ICH/FDA/EU regulations and guidelines
• Proficient in using Microsoft applications (MS Word, MS Excel, MS PowerPoint)
• Must be able to demonstrate ability to gown aseptically
• Good/effective communication and organizational skills
• Ability to work well with others and independently
• Ability to work outside of normal business hours, including nights, weekends and holidays
• Regularly sit for long periods of time
• Frequently required to stand, use hands to finger, handle, or feel, and reach with hands and arms
• Occasionally required to walk, climb or balance, stoop, kneel, crouch, or crawl

Benefits

• Paid vacation days, amount based on tenure
• Paid sick time
• 10 observed holidays + 2 floating holiday + 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 & vision care
• Employer-paid basic term life/personal accident insurance
• Voluntary disability, universal life/personal accident insurance
• Accidental Death & Dismemberment (AD&D) Insurance

Before you apply

• Criminal background check required
• Genezen is not able to sponsor visas

About the company

Genezen provides process development, produces GMP viral vectors, and provides cell transduction for gene and cell therapy clinical trials.