Operations Compliance Specialist

Role Summary

The Operations Compliance Specialist serves as the compliance expert within the Operations department. This role is responsible for identifying, resolving, and improving safety and quality compliance issues, as well as driving continuous improvement in these areas. The position also ensures alignment with regulatory requirements, corporate policies, and safety practices across operations.

Responsibilities

• Investigate and resolve production issues, determining root causes and implementing corrective actions.
• Own and manage compliance records, including deviations, CAPAs, change controls, and events.
• Ensure compliance with SOPs, cGMP, regulatory standards, and safety protocols.
• Oversee quality self-inspections, develop inspection schedules, and train resources to conduct them effectively.
• Conduct regular compliance audits and process confirmations in assigned areas.
• Monitor and direct deviation teams to meet system requirements and continuously improve deviation processes.

Technical Process Support

• Provide expertise in the scale-up and transfer of new products or processes, ensuring alignment with operational and environmental factors.
• Perform reviews of protocols, risk assessments, and compliance records, ensuring thorough documentation and adherence to standards.

Operational Excellence

• Apply Lean Six Sigma tools to drive continuous improvement in quality, cost, safety, and cycle time.
• Ensure timely completion of deviations and implement necessary improvements to the deviation system.

EHS Responsibilities – All Associates

• Know, understand, and comply with all Environment, Health, and Safety (EHS) guidelines. Report unsafe conditions, all injuries, illnesses, and hazardous materials releases. Wear personal protective equipment, attend EHS training programs, and follow all safe work procedures.

Quality Responsibilities – All Associates

• Adhere to all Quality Compliance standards (Data Integrity, QA, QC, etc.) including QMS policy and regulatory requirements.

Why you?

Basic Qualifications

• A minimum of a HS Diploma or GED is required.
• A minimum of 2 years of related experience (technical and/or deviation writing in a manufacturing environment, or other relevant experience) is required.
• Experience managing compliance related projects
• Familiarity with manufacturing operations

Preferred Qualifications

• A Bachelor‚Äôs degree is preferred.
• Packaging experience is preferred.
• Strong knowledge of cGMPs, SOPs, OSHA/FDA/EMEA regulations.
• Strong interpersonal skills, effective communication, and the ability to influence others.
• Proficiency in Microsoft Office applications and inventory control software (SAP).
• Knowledge of cGMP requirements and experience in FDA-regulated environments.
• Demonstrated project management skills and experience with quality initiatives, including validation protocols, deviation reports, and root cause analysis.

Location

This role is based in: St Louis, MO. This is not a remote opportunity.