Operations Compliance Specialist

Operations Compliance Specialist

Position Summary:

Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO), and Our purpose-built San Diego location provides comprehensive clinical supply services including clinical supply management, primary and secondary packaging, complex labeling services, clinical storage, distribution, and clinical returns and destruction, and will also include stability chambers. Located less than a mile from Catalent's West Coast early-phase oral drug product development center of excellence, customers choosing this convenient Catalent location can now enjoy a fully integrated development, clinical supply manufacturing and distribution solution.

The Operations Compliance Specialist ensures patient safety, regulatory compliance, and inspection readiness by leading investigations and managing deviations and complaints with precision and accountability. This role facilitates Rapid Response Team fact-gathering, authors clear and comprehensive investigation reports, and proposes effective Corrective and Preventive Actions (CAPAs) to prevent recurrence of quality events. Leveraging industry-standard Lean and Six Sigma tools, the Specialist drives root cause analysis (RCA), leads cross-functional problem-solving sessions, and develops Standard Operating Procedures (SOPs) and work instructions to strengthen operational standards.

The Role:

• Participate in and facilitate Rapid Response Team fact gathering
• Write Investigation reports – These written reports will clearly communicate what happened, why it happened, when it happened
• Propose CAPAs – how to prevent event from happening in the future. Author SOPs and work instructions
• Deploy industry-standard lean and six sigma tools to address the root causes of non-conforming quality events
• Review investigation documentation for Out of Spec/Trend (OOS/T) or atypical results, as well as deviations from regulations, corporate policy or site procedures
• Manage timelines for investigations/complaints to ensure that reporting is performed on time and investigations/complaints are addressed in a timely manner
• Facilitate cross-functional problem-solving events. Communicates clearly with internal and external clients, both verbal and written. Use clear understanding of related SOPs and cGMPs as necessary to accomplish daily tasks
• Other duties as assigned

The Candidate:

• Bachelor's degree required, preferably in Science, Engineering, Pharmaceutical Sciences, or a related field. Lean Six Sigma certification and experience is highly desirable
• Minimum of five (5) years of relevant industry experience in a cGMP environment, or comparable pharmaceutical knowledge and experience
• Minimum of three (3) years of technical writing such as validation reports, engineering documents, controlled documents (SOPs, Batch Records, Work Instructions) in a GMP environment
• Strong knowledge of Microsoft Office software and query-based systems activities (e.g., Pivot Tables, VLOOKUP's, Excel Formulas, building presentations in PowerPoint, etc.).
• Preferred knowledge of systems – JD Edwards 9.2, DSI, GSA, Supply Flex, Compliance Wire, Track Wise, EDMS, etc.
• Ability to simultaneously work on several projects with the flexibility to reprioritize in a minimum amount of time. Must be able to communicate effectively with internal and external customers, peers and managers
• Physical requirements:
  
  able to perform duties which include standing, walking, sitting frequently and significant amount of use of office equipment and computers, keyboards, and writing by hand;
  Must be able to lift up to 35lbs and work in temperature-controlled freezers/fridges occasionally

Pay:

• The anticipated salary range for this role in San Diego, CA is $75,000 to $85,000 annually. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc.
  
  Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.

Why you…