GMP QC Chemist - HPLC & Lab Analysis

Biovire, Inc.; Michigan; On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k)

Job summary

Biovire, Inc. in Brighton, Michigan is seeking a Quality Control Chemist to support analytical testing and release activities for materials and products produced at our Brighton facility.

You will perform USP/HPLC testing, document results, coordinate outside testing, and help maintain laboratory instruments while ensuring cGMP compliance in a fast-paced environment. This role offers growth in analytical sciences within a collaborative GMP setting and exposure to sterile manufacturing processes.

Qualifications

• 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.
• 1–2 years of HPLC experience preferred.
• Working knowledge of chromatography data systems and Microsoft Office.
• 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.

Skills

HPLC experience

cGMP knowledge

Laboratory testing

Documentation skills

Data analysis

Education

Bachelor's degree in Chemistry

Tools

Agilent OpenLab CDS

Agilent ChemStation

Job description

Biovire, Inc. in Brighton, Michigan is seeking a Quality Control Chemist to support analytical testing and release activities for materials and products produced at our Brighton facility.

You will perform USP/HPLC testing, document results, coordinate outside testing, and help maintain laboratory instruments while ensuring cGMP compliance in a fast-paced environment. This role offers growth in analytical sciences within a collaborative GMP setting and exposure to sterile manufacturing processes.