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)

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

Permanent