Quality Associate, Pharmaceutical Manufacturing (GMP), 10PM-8AM Monday-Thursday

Job Description

Job Description

Quality Associate – Pharmaceutical Manufacturing

At Codis (formerly Particle Dynamics), we help bring complex pharmaceutical, nutraceutical, and consumer health products to life through science, precision, and manufacturing excellence.

As a next-generation global Contract Development & Manufacturing Organization (CDMO), Codis partners with leading health and wellness companies to develop and manufacture innovative products using advanced technologies such as spray drying, amorphous solid dispersions, microencapsulation, and continuous granulation. With major cGMP manufacturing facilities in the US and UK, over 400,000 square feet of compliant manufacturing space, and decades of particle engineering expertise, Codis delivers quality, reliability, and innovation at scale.

We are currently seeking a detail-oriented and quality-driven Quality Associate to join our Pharmaceutical Manufacturing facility in St. Louis/Brentwood .

Position Summary

The Quality Associate plays a vital role in ensuring products manufactured at Codis meet all quality, safety, regulatory, and customer requirements prior to release. This position supports quality assurance and quality control functions through sampling, testing, inspection activities, documentation review, environmental monitoring, and cGMP compliance auditing within a regulated pharmaceutical manufacturing environment.

This role serves as an important checkpoint between manufacturing execution and product release. Every inspection, sample, calculation, and review helps ensure that products delivered to customers and patients meet the highest standards of quality and compliance.

Essential Duties & Responsibilities

• Perform sampling and testing of:
• Raw materials
• Finished products
• Stability samples
• In-process materials
• Rinse water and purified water
• Conduct routine inspections of manufacturing areas, equipment, and personnel to ensure compliance with cGMP requirements
• Review batch records, manufacturing documentation, and analytical results for completeness and accuracy prior to product release
• Monitor manufacturing processes for proper material usage, accurate documentation, and prevention of cross-contamination
• Assist with investigations involving deviations, out-of-specification results, and corrective actions
• Support validation activities and protocol sampling as required
• Maintain laboratory and testing equipment cleanliness and organization
• Monitor, archive, print, and file environmental and temperature/humidity data
• Verify calibration status of production instruments and communicate discrepancies to leadership
• Initiate rejection documentation for materials or products not meeting specifications
• Inspect and approve equipment readiness following product changeovers
• Assist with reserve sample management and destruction activities per QA authorization
• Support process and cleaning validation sampling activities
• Notify management of quality discrepancies and assist manufacturing teams with resolving processing issues
• Maintain accurate and timely GMP documentation and records
• Follow all Codis SOPs, FDA regulations, safety standards, and quality requirements
• Work collaboratively with Quality, Manufacturing, and Site Leadership teams
• Perform additional duties as assigned to support departmental and company objectives

Qualifications

Education & Experience

• Some college-level coursework in Biology, Chemistry, Mathematics, or related scientific fields preferred
• Equivalent quality assurance or quality control experience may be considered in place of formal education
• Preference given to candidates with:
• Scientific degrees
• GMP manufacturing experience
• Pharmaceutical quality experience
• Minimum two (2) years of experience in pharmaceutical quality inspection, auditing, or quality assurance preferred
• Experience with:
• Raw material sampling
• In-process inspections
• Finished product inspections
• QA physical testing procedures
• Sampling and testing equipment

Knowledge, Skills & Abilities

• Ability to understand and apply Good Manufacturing Practices (cGMPs) and Standard Operating Procedures (SOPs)
• Strong attention to detail and documentation accuracy
• Ability to read, comprehend, and revise technical procedures and records
• Strong written and verbal communication skills
• Ability to accurately perform mathematical calculations related to quality testing and documentation
• Ability to use laboratory and quality equipment including:
• Scale balances
• Micrometers
• Calculators
• Computer systems
• Strong organizational, analytical, and problem-solving skills
• Ability to maintain professionalism and work collaboratively across departments
• Ability to identify and communicate quality concerns effectively
• Conflict resolution and teamwork skills
• Understanding of clean processing environments and contamination control principles

Work Environment

• cGMP-regulated pharmaceutical manufacturing facility
• Clean, climate-controlled manufacturing and laboratory environment
• Combination of laboratory, manufacturing floor, and office-based responsibilities
• Requires strict adherence to quality systems, documentation practices, and FDA regulations

Why You'll Love Working Here

• Competitive pay based on experience and performance
• Health, dental, vision, and life insurance effective the 1st day of the month following hire
• 401(k) with immediate vesting
• 100% match on the first 3%
• 50% match on the next 2%
• Paid time off available upon hire:
• 80 hours vacation
• 56 hours sick time
• 10 paid holidays annually effective upon hire
• Uniforms, safety shoes, and safety glasses provided by the company
• Clean, climate-controlled pharmaceutical environment
• Supportive team culture with opportunities for growth and training
• Strong focus on work/life balance compared to larger manufacturing operations

Codis is proud to be an Equal Opportunity Employer.