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Quality Associate - Pharmaceutical Manufacturing

Codis -
Seymour, IN

Quick Apply

Job Details

Full-time
7 days ago

Benefits

Paid holidays
Health insurance
Dental insurance
Paid time off
Vision insurance
401(k) matching
Life insurance

Qualifications

Laboratory sample storage
USP standards
Stability testing
Temperature-controlled storage
Raw material quality management
Document review (document control)
Laboratory inventory control
Quality records maintenance
Laboratory equipment routine checks
Stability studies in drug product development
Pharmaceutical laboratory environment
Safety regulations
Cold chain logistics
Corrective and preventive actions (CAPA)
Internal investigations
Laboratory test results documentation
Inspection reporting and documentation
Laboratory equipment calibration
Data summary reports
Quality reports
Manufacturing standard operating procedures
Manufacturing facility experience
Data integrity and documentation
Analysis skills
Laboratory reports
Laboratory quality control records management
Continuous improvement
Pharmaceutical company experience
Pharmaceutical analysis
Raw materials management

Full Job Description

Quality Associate

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.

Quick Apply

Refine Your Search

quality associate pharmaceutical manufacturing jobs in columbus, in

Quality Associate - Pharmaceutical Manufacturing

Production Associate (1st and 3rd Shift)

Production Associate 2nd Shift (Spray Dryer Facility) - Pharmaceutical Manufacturing 3PM-11:30PM

Production Line Lead - Updated Pay Ranges!

Production Associate 3rd Shift (Spray Dryer Facility) - Pharmaceutical Manufacturing 11PM-7:30AM

Maintenance Tech level 2

Principal Scientist Technical Services

(USA) Facilities Maintenance Manager, Licensed Master Electrician

Director, Regulatory Affairs – CMC

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