Night-Shift Quality Associate, GMP & Lab QA

Codis; Seymour (IN); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

PTO from day one

Competitive pay

Health insurance

Dental insurance

Vision insurance

Life insurance

401(k) match

Climate-controlled environment

Growth opportunities

10 holidays

Job summary

Codis in Seymour, IN is hiring a Quality Associate for the 3rd shift (11:00 PM – 7:30 AM). You will perform testing, maintain documentation, and ensure compliance with SOPs and regulatory standards in a climate-controlled pharmaceutical environment.

Primary responsibilities include batch review, stability programs, instrument calibration, and investigations to support quality assurance across production lines. Lifting flexibility and strong teamwork are expected.

Qualifications

• Experience in quality assurance or laboratory environment (pharmaceutical/manufacturing preferred).
• Familiarity with GMP, FDA, and regulatory standards.
• Strong attention to detail and documentation accuracy.
• Ability to work independently and communicate across departments.

Responsibilities

• Perform and document incoming, in-process, and finished product testing to ensure accuracy and compliance.
• Conduct line checks, start-up checks, and cleaning verifications.
• Review batch records and manufacturing documentation for completion and compliance.
• Report discrepancies to management and implement corrective actions.
• Perform USP water sampling and Environmental Monitoring per procedures.
• Monitor product quality through laboratory testing and data analysis.
• Prepare COA, COC, and COT as needed.
• Manage reagent inventory and retention samples; support stability program.
• Coordinate calibration of instruments with maintenance; ensure storage controls.

Skills

Quality assurance

Laboratory testing

GMP compliance

Documentation accuracy

Cross-functional communication

Independent worker

Job description

Codis in Seymour, IN is hiring a Quality Associate for the 3rd shift (11:00 PM – 7:30 AM). You will perform testing, maintain documentation, and ensure compliance with SOPs and regulatory standards in a climate-controlled pharmaceutical environment.

Primary responsibilities include batch review, stability programs, instrument calibration, and investigations to support quality assurance across production lines. Lifting flexibility and strong teamwork are expected.