Quality Control Chemist

Biovire • Brighton, MI

12h • Onsite

About The Position

Biovire is advancing toward commercialization with a focus on quality, precision, and operational excellence in a GMP-regulated environment. We are seeking a Quality Control Chemist to join our Quality Control team and support laboratory testing and release activities for materials and products manufactured at our Brighton facility. The Quality Control Chemist performs analytical laboratory testing to support the release of excipients, active pharmaceutical ingredients (APIs), raw materials, and finished drug products. This role works within a cGMP-regulated laboratory environment and is responsible for accurate testing, documentation, sample coordination, and laboratory support activities that help ensure products meet established quality and regulatory requirements.

Requirements

• Bachelor's degree in Chemistry, Biology, or a related Life Science.
• 2+ years of pharmaceutical industry or equivalent relevant laboratory experience.
• Familiarity with cGMP and regulatory principles, including deviations and CAPAs.
• Familiarity with USP/NF, FDA, ICH guidance, and cGMP requirements.
• Working knowledge of chromatography data systems and Microsoft Office.
• Strong mathematical, organizational, and data-analysis skills with excellent attention to detail.
• Ability to prioritize work effectively in a fast-paced laboratory environment.
• Strong written and verbal communication skills and the ability to work effectively as part of a cross-functional team.

Nice To Haves

• 1–2 years of HPLC experience preferred.
• Experience with Agilent OpenLab CDS or Agilent ChemStation is a plus.

Responsibilities

• Perform testing of incoming components, excipients, APIs, and finished drug products using wet chemistry, dimensional analysis, analytical instrumentation with an emphasis on HPLC, and applicable microbiological techniques.
• Perform testing according to internal procedures and USP requirements in compliance with cGMP and applicable regulatory expectations.
• Accurately document laboratory testing and results in accordance with cGMP documentation practices.
• Coordinate testing performed by contract laboratories, including sample preparation and shipment.
• Author and revise SOPs, test methods, specifications, and other controlled laboratory documents.
• Support maintenance, troubleshooting, calibration, and onboarding of laboratory analytical instrumentation.
• Assist Analytical Services with mentored method validation activities as needed.
• Support laboratory operations including consumables inventory, housekeeping, glassware management, and maintenance of a clean and organized laboratory environment.
• Perform work safely using appropriate procedures and personal protective equipment.
• Partner with colleagues across Quality and other functions to support testing priorities and production schedules without compromising product quality.

Benefits

• Comprehensive employee benefits including medical, dental, vision, and life insurance
• Competitive Paid Time Off supporting work-life balance
• Company-sponsored events and team activities

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level