Recruiter :
Darren Nelson
- Perform QC testing on materials and products.
- Monday-Friday, transitioning to 3rd shift.
- Bachelor's in science, 1-3 years lab experience.
Job Title: Quality Control (QC) Analyst
Job Type: Full-Time | Contract
Location: Aurora, OH, 44202
Schedule:
Pay Rate: $22.00/hour
FLSA Status: Non-Exempt
Duration: ~7 months (212 days)
Job Summary
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.
Key Responsibilities
Qualifications:
Education:
Experience:
Knowledge, Skills & Abilities
Work Environment & Physical Requirements
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)
Job Summary
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.
Key Responsibilities
- 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 bioburden, 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.
Qualifications:
Education:
- Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Microbiology)
Experience:
- 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)
Knowledge, Skills & Abilities
- 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 Environment & Physical Requirements
- 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
