Operations Compliance Specialist

Zoetis • Kalamazoo, MI

1d

About The Position

The Operations Compliance Specialist is responsible for investigating product and process deviations related to Zoetis’ animal health pharmaceuticals. This role ensures that all deviations are thoroughly analyzed using structured methodologies such as DMAIC (Define, Measure, Analyze, Improve, Control), root causes are identified, and corrective and preventive actions (CAPAs) are implemented to maintain compliance with regulatory standards and ensure product quality.

Requirements

• Education: Bachelor's degree in Engineering, Life Sciences, or a related field is strongly preferred.
• Candidates with a High School diploma or equivalent with appropriate deviation-related experience will also be considered.
• Experience: Minimum of 3 years of experience in deviation investigation, quality assurance, or compliance in the pharmaceutical or biotechnology industry.
• Familiarity with DMAIC methodology and tools is strongly preferred.
• Skills: Strong analytical and problem-solving skills, including Root Cause Analysis and DMAIC tools (e.g., process mapping, Fishbone diagrams, and 5-why analysis).
• Excellent technical writing and documentation skills with the ability to integrate structured methodologies into reports.
• Ability to work independently and as part of a team.
• Knowledge of regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., GMP).
• Proficiency in using quality management systems and investigation tools.
• Strong communication and presentation skills.

Responsibilities

• Deviation Investigation: Conduct thorough investigations of deviations using DMAIC tools to ensure a structured and data-driven approach.
• Partner with SMEs, Quality, and Area Support to define the scope of the deviation (Define phase), measure its impact, and identify root causes through tools such as fishbone diagrams, process mapping, and 5-why analysis (Measure and Analyze phases), and develop and implement CAPAs to address root causes and prevent recurrence (Improve and Control phases).
• Documentation: Prepare detailed investigation reports, integrating DMAIC principles to document findings, root cause analysis, and CAPAs.
• Maintain accurate and up-to-date records of all investigations, ensuring they reflect a systematic approach to problem-solving.
• Compliance Monitoring: Ensure all operations comply with regulatory requirements, company policies, and industry standards.
• Process Improvement: Collaborate with cross-functional teams to identify opportunities for process improvements using DMAIC tools to enhance product quality and compliance.
• Implement proactive improvements as well as CAPAs, ensuring control mechanisms are in place to sustain changes.
• Audits: Participate in internal and external audits, providing necessary documentation and explanations related to deviation investigations.
• Act as a representative in defending deviations during regulatory audits.
• Provide clear, evidence-based explanations and justifications for deviations from standard processes and procedures, supported by DMAIC-based findings.
• Compile and organize comprehensive documentation to support deviation defenses, ensuring all records reflect a systematic and structured problem-solving approach.
• Represent Zoetis with professionalism, maintaining open and transparent communication with regulatory agencies.
• Address concerns promptly and effectively, ensuring a thorough understanding of the context and corrective actions taken.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level