Quality Control; QC Analyst

• Job Title: Quality Control (QC) Analyst
• Job Type: Full-Time | Contract
• Location: Aurora, OH, 44202
• Schedule: Initial Shift: Monday–Friday, 7:00 AM – 3:30 PM;
  Transition to: 3rd Shift | Sunday–Thursday, 11:00 PM – 7:00 AM
• Pay Rate: $22.00/hour
• FLSA Status: Non-Exempt
• Duration: ~7 months (212 days)

As a Quality Control Analyst
, you will play a critical role in ensuring the safety, quality, and compliance of raw materials and finished products by performing analytical and microbiological testing in a Quality Control (QC) laboratory. This role supports manufacturing operations by adhering to cGMP standards and regulatory guidelines.

• Perform routine and non-routine chemical and microbiological analyses of raw materials, in-process samples, and final products according to established specifications.
• Operate and maintain laboratory instrumentation (e.g., pH meter, conductivity meter, UV-Vis, Karl Fischer, FTIR, titrators) following standard procedures.
• Apply compendial methods (USP, EP, BP, JP, ACS) and EXCIPACT standards in testing activities.
• Calculate, record, and interpret analytical data for compliance, entering results into LIMS.
• Conduct environmental monitoring in classified cleanroom areas, including air and surface sampling (requires full gowning).
• Perform technical reviews of data, water testing, and environmental monitoring results.
• Investigate out-of-spec results, support complaint resolution, and assist in instrument troubleshooting.
• Apply appropriate material disposition labeling (e.g., accepted/rejected).
• Author, revise, and review laboratory SOPs and instrument work instructions.
• Conduct microbiological assays, including bioburdstream, endotoxin, DNase, RNase, protease, and phosphatase, using aseptic technique.
• Prepare and dispose of microbial media following safety protocols.
• Handle hazardous materials while following proper PPE and safety procedures.
• Support sampling and testing of USP Purified Water and Water for Injection (WFI).
• Ensure accurate, complete, and legible documentation in compliance with GMP and internal procedures.

• Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Microbiology)

• 1–3 years of laboratory experience in a regulated QC or related environment
• Experience in wet chemistry and microbial testing preferred (e.g., titrations, water content, bioburden, endotoxin testing)

• Proficient in the use of laboratory instruments and analytical techniques
• Familiar with LIMS and Microsoft Office Suite (Excel, Word, PowerPoint, Access)
• Strong attention to detail with excellent problem-solving and analytical skills
• Effective written and verbal communication skills
• Ability to work both independently and collaboratively in a fast-paced, regulated environment

• Work primarily in a laboratory setting with standard lighting, ventilation, and noise levels
• Occasional exposure to chemicals (flammables, oxidizers, corrosives) with proper PPE
• Moderate physical activity may be required: standing, walking, reaching, and lifting objects up to 10 lbs
• Must be comfortable working in cleanroom environments and wearing full gowning when necessary