Pharma Quality Associate 2nd Shift Lab QA

Codis; Seymour (IN); On-site; USD 30,000 - 47,000; Full time

Benefits offered by this job

Paid time off

Health insurance

Dental insurance

Vision insurance

Life insurance

401(k) match

Climate-controlled environment

Growth opportunities

10 holidays per year

Job summary

Codis is seeking a Quality Associate for the Seymour, IN site to ensure a broad range of products meet quality, safety, and regulatory standards through testing, documentation, and SOP adherence.

Responsibilities include testing, line and startup checks, batch record reviews, and CAPA support. The role requires GMP/FDA knowledge, strong attention to detail, and collaboration across departments on third-party audits and continuous improvement.

Qualifications

• Prior experience in a quality assurance or laboratory environment.
• Working knowledge of GMP, FDA, and regulatory standards.
• Strong attention to detail, documentation accuracy, and analytical skills.
• Ability to work independently and communicate effectively across departments.

Responsibilities

• Perform and document incoming, in-process, and finished product testing to ensure accuracy, compliance, and product integrity.
• Conduct line checks, start-up checks, and cleaning verifications to support operations.
• Review batch records and manufacturing documentation for completion and compliance.
• Maintain retention samples and documentation for raw materials and finished products.
• Coordinate with maintenance to ensure laboratory instruments and data loggers are calibrated and compliant.
• Participate in internal audits, continuous improvement initiatives, and change control processes.

Skills

Quality assurance

Laboratory testing

Documentation

Regulatory knowledge

Attention to detail

Independent worker

Tools

GMP training

Job description

Codis is seeking a Quality Associate for the Seymour, IN site to ensure a broad range of products meet quality, safety, and regulatory standards through testing, documentation, and SOP adherence.

Responsibilities include testing, line and startup checks, batch record reviews, and CAPA support. The role requires GMP/FDA knowledge, strong attention to detail, and collaboration across departments on third-party audits and continuous improvement.