Quality Associate, 2nd Shift - Pharmaceutical Manufacturing

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

Quality Associate - 2nd Shift (3:00PM - 11:30PM)

Pay rate based on experience!

About Codis

At Codis (formerly Particle Dynamics), we manufacture high-quality pharmaceutical, nutraceutical, food, and over-the-counter products that support better health worldwide. We're a three-shift operation with a close-knit team that values collaboration, growth, and hands‑on learning.

Why You'll Love Working Here

• Paid time off available from day one - no waiting period - 80 hours of vacation and 56 hours of sick/personal time annually
• Competitive pay for experience and performance
• Health, dental, vision, and life insurance effective the 1st of the month after hire
• 401(k) match: 100% match on the first 3% contributed, and 50% match on the next 2% - with immediate vesting
• Clean, climate‑controlled pharmaceutical environment
• Growth opportunities within a supportive and collaborative environment
• 10 paid holidays per year, effective upon hire

Position Summary

We are currently seeking a Quality Associate to join our Seymour Quality team. This position plays a key role in ensuring that all products meet quality, safety, and regulatory standards through testing, documentation, and compliance with internal and external requirements. The Quality Associate performs all activities in accordance with Codis' Standard Operating Procedures (SOPs) and applicable regulations (FDA, EU, USP/NF, etc.).

Primary 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.
• Report any discrepancies or non‑conformances immediately to management.
• Conduct USP water sampling and testing and Environmental Monitoring per established procedures.
• Monitor product quality through chemical and physical laboratory testing.
• Prepare Certificates of Analysis (C of A), Certificates of Compliance (C of C), and Certificates of Testing (C of T) as needed.
• Manage reagent inventory and ensure adequate supplies for production schedules.
• Maintain retention samples and documentation for raw materials and finished products.
• Administer the stability program, ensuring timely collection, testing, and reporting of stability samples.
• Coordinate with maintenance to ensure laboratory instruments and data loggers are calibrated and compliant.
• Monitor and document temperature control for warehouse and refrigerated storage areas.
• Perform incoming material sampling, testing, and disposition according to procedures.
• Maintain organized laboratory notebooks, cleanliness, and order.
• Participate in internal audits, continuous improvement initiatives, and change control processes.
• Assist in investigations (NOEs), write summary reports, and recommend CAPAs as needed.
• Review compendial methods annually and initiate change control when required.
• Perform other related duties as assigned.

Qualifications

• Prior experience in a quality assurance or laboratory environment within pharmaceutical or related manufacturing preferred.
• 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.
• Flexibility to support other shifts or tasks as business needs arise.