Quality Associate, 2nd Shift - Pharmaceutical Manufacturing

Codis
  • Seymour, IN
  • Full-time
  • Instant Apply
Today

Job Description

Quality Associate - 2nd Shift (3:00PM - 11:30PM)Pay rate based on experience!About CodisAt 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 HerePaid time off available from day one - no waiting period - 80 hours of vacation and 56 hours of sick/personal time annuallyCompetitive pay for experience and performanceHealth, dental, vision, and life insurance effective the 1st of the month after hire401(k) match: 100% match on the first 3% contributed, and 50% match on the next 2% - with immediate vestingClean, climate-controlled pharmaceutical environmentGrowth opportunities within a supportive and collaborative environment10 paid holidays per year, effective upon hirePosition 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 ResponsibilitiesPerform 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.QualificationsPrior 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. 

Numbers & Facts

LocationSeymour, IN
Job TypeFull-time

Skills

  • Analysis Skillsunmatched
  • Biotech and Pharmaceuticalunmatched
  • Change Controlunmatched
  • Communication Skillsunmatched
  • Continuous Improvementunmatched
  • Detail Orientedunmatched
  • Documentationunmatched
  • Drug Manufacturingunmatched
  • Environmental Monitoringunmatched
  • FDA Requirementsunmatched
  • GMP (Good Manufacturing Practices)unmatched
  • Insuranceunmatched
  • Internal Auditunmatched
  • Inventory Managementunmatched
  • Laboratory Notebookunmatched
  • Laboratory Testingunmatched
  • Maintain Complianceunmatched
  • Manufacturingunmatched
  • Materials Testingunmatched
  • Operational Auditunmatched
  • Operational Supportunmatched
  • Organizational Skillsunmatched
  • Physical Chemistryunmatched
  • Precision Testingunmatched
  • Procedure Developmentunmatched
  • Product Supportunmatched
  • Product Testingunmatched
  • Production Scheduleunmatched
  • Quality Assuranceunmatched
  • Quality Monitoringunmatched
  • Regulationsunmatched
  • Reporting Skillsunmatched
  • Safety Standardsunmatched
  • Standard Operating Procedures (SOP)unmatched
  • Startupunmatched
  • Team Playerunmatched
  • Testingunmatched
  • Time Managementunmatched
  • Warehousingunmatched
  • Water Quality Testingunmatched
  • Water Samplingunmatched

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