Quality Control Analyst

1 week ago

Minneapolis, Minnesota, United States firstPRO, Inc Full time

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 practices
  • Contamination control methodologies
  • Endotoxin, bioburden, and related microbiological assays
  • Critical utility sampling
  • Experience 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.

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