You are a Quality Assurance Associate involved with ensuring compliance with quality standards and supporting the smooth functioning of manufacturing and quality control operations. You will contribute to the overall quality assurance efforts by managing controlled documentation, equipment programs, and raw material releases.

Location: Paris, KY

Compensation: $25.75/hr

Schedule: 12hr shifts 6:00pm-6:00am

                        Rotating 3 on, 2 off, 2on, 3 off

What You Will Be Doing:

• Issue controlled manufacturing and testing documents to Manufacturing and Quality Control as per production schedules.
• Issue controlled labels for labeling finished goods and related samples.
• Monitor equipment calibration and preventative maintenance schedules and provide quality assurance sign-offs for equipment work orders.
• Manage the issuance and reconciliation of equipment and room logbooks.
• Coordinate raw material release by reviewing and approving supporting documentation, including supplier and quality control testing records.
• Conduct reconciliation, filing, and archiving of quality-controlled records; store documents in appropriate data files and coordinate off-site storage when necessary.
• Provide pre-run line clearance to manufacturing as required.
• Resolve discrepancies by consulting with document originators.
• Collaborate with internal departments to ensure timely fulfillment of customer commitments.
• Manage the Label Program, including developing master labels, maintaining controlled label stock, setting inventory safety levels, and coordinating reorders.
• Support batch record reviews when necessary.
• Write and revise SOPs as part of process improvements or as needed to support the department.
• Coordinate document control activities and delegate tasks to quality coordinators under the direction of quality management.
• Actively contribute to the quality and safety culture of the site.
• Perform additional duties as assigned.

What You Bring:

• Education: BA/BS in chemistry or related science field preferred, or equivalent education and experience.
• Experience: Entry level experience in Quality Assurance, with knowledge of cGMP and ISO standards.
• Skills: Proficiency in MS Word, PowerPoint, Excel; ability to read, analyze, and interpret technical documents; report and procedure writing skills.
• Knowledge: Understanding quality assurance, quality control, and operations in a regulated environment.
• Familiarity with lab equipment operation and set-up.
• Strong communication and presentation skills, with the ability to engage with all levels of the company.
• Great team player with strong interpersonal skills.

 To learn more about the workplace culture and the position, please apply!
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