Job Title: Quality Control Analyst
Location: Brooklyn Park, MN 55445
Duration: 12 Months (Possible Extension)
Work Arrangement: Onsite
 
Position Summary
The Quality Control Analyst will independently perform and review routine in-process, drug substance, and stability testing to support manufacturing and product quality. This role involves working with a wide range of analytical instruments, maintaining lab operations, documenting data accurately, and ensuring compliance with cGMP and internal quality standards.
 
Key Responsibilities
Testing & Data Management

• Perform and review routine in-process, drug substance, and stability test methods in a timely manner.
• Use laboratory instruments and software such as LIMS, SoftmaxPro, Charles River Endoscan, MODA, and Empower to collect and record data.
• Conduct testing for environmental monitoring, critical utilities, and stability samples.

Quality & Compliance

• Maintain data integrity and adhere to company SOPs, specifications, and cGMP regulations.
• Initiate, author, and own quality system events, including laboratory investigations, deviations, CAPAs, and change controls.
• Complete all assigned testing—including project or protocol-based—accurately and within required timelines.

Lab Operations & Maintenance

• Support daily laboratory operations, including reagent preparation, supply ordering, equipment cleaning, waste disposal, and restocking.
• Perform equipment maintenance, calibrations, and troubleshooting as required.

Training & Documentation

• Demonstrate strong understanding of lab operations and SOPs.
• Train new QC Analysts on routine procedures and best practices.

 
Qualifications & Experience
Education

• Bachelor’s or Master’s degree in Life Sciences or related discipline with relevant laboratory coursework.

Experience

• 3–6 years of relevant lab or QC experience preferred.
• Prior experience in a regulated environment (FDA, GMP, cGMP) is preferred.
• Strong understanding of laboratory instrumentation and cGMP manufacturing principles.

Technical Skill Sets
QC Analytical Skills

• HPLC, UPLC
• Appearance, concentration, pH
• Capillary electrophoresis
• Osmolality
• TOC
• Strong micropipetting skills

QC Bioassay Skills

• ELISAs
• Cell maintenance and cell-based assays
• Gels, icIEF
• Aseptic technique
• Strong micropipetting skills

QC Microbiology Skills

• Contamination control
• Endotoxin & bioburden testing
• Environmental monitoring
• Manufacturing cleanroom procedures
• Aseptic technique

Critical utility systems (e.g., water systems) 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 32.00/hr.