QC Analyst – Microbiology (Contract Role)
Location : Brooklyn Park, MN (Onsite)
Employment Type : Contract
A fast-paced biopharmaceutical manufacturing site is seeking a QC Analyst with strong microbiology experience to support routine testing, environmental monitoring, and quality system activities. This role is hands-on in the lab and supports product quality, compliance, and operational readiness across multiple departments.
Overview of Responsibilities
Laboratory Testing & Sample Analysis
- Perform microbiological and analytical testing for in-process materials, drug substances, stability studies, and facility-related samples.
- Complete environmental and critical utility monitoring, including viable / non-viable sampling in controlled areas.
- Use laboratory software systems such as LIMS, MODA, and endotoxin testing platforms to record, review, and manage data.
- Prepare reagents, maintain lab supplies, manage waste streams, and ensure laboratory spaces remain inspection-ready.
Quality & Compliance
Generate and manage quality documentation including deviations, investigations, change controls, and CAPA records.Follow all SOPs and maintain strict compliance with cGMP and data integrity guidelines.Apply sound judgment in troubleshooting method, equipment, or data-related issues within established QC practices.Cross-Functional Interaction
Work closely with Manufacturing, Quality, Validation, Engineering, and other internal partners to support testing needs and timelines.Participate in method revisions, SOP updates, and continuous improvement initiatives.Execute project-specific or protocol-driven testing as required.Equipment & Training
Perform routine instrument checks, maintenance, and calibration activities.Keep training records up to date and complete required coursework within assigned timelines.Required Qualifications
Bachelor’s or Master’s degree in a Life Science discipline.3–6 years of laboratory experience preferred.Experience in a regulated environment (GMP or similar) strongly preferred.Familiarity with laboratory instruments, EM programs, and microbiological techniques.Strong communication skills and ability to work effectively within a team setting.Comfortable using standard computer programs (Word, Excel, databases, etc.).Knowledge of biological, chemical, and / or microbiological safety practices.Technical Competencies
Environmental Monitoring (viable and non-viable)Cleanroom gowning and aseptic practicesContamination control methodologiesEndotoxin, bioburden, and related microbiological assaysCritical utility samplingExperience with lab systems (e.g., LIMS, MODA, Endotoxin testing platforms)Role Complexity
Work includes moderately complex tasks requiring accuracy and strong attention to detail.Receives guidance on new tasks but expected to operate independently once trained.Contributes to decision-making based on scientific reasoning, regulatory expectations, and established procedures.Physical & Work Environment Requirements
Ability to stand or sit for extended periods in both lab and office settings.May be required to lift items up to 30 lbs, climb small ladders, and perform cleanroom gowning.Daily use of PPE including safety glasses, gloves, lab coats, and sterile garments depending on assigned areas.