Operations Compliance Specialist

Operations Compliance Specialist

Position Summary : 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, and 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 :

High School Diploma / GED required. Bachelor of Science in Engineering, Pharmaceutical Sciences, or a related field is highly preferred. Lean Six Sigma certification is highly desirable.

Minimum of two (2) years of experience with pharmaceutical packaging and distribution processes, Standard Operating Procedures (SOPs) and GxPs.

Minimum of one (1) year of experience with technical writing such as validation reports, engineering documents, controlled documents (SOPs, Batch Records, Work Instructions) in a GxP environment.

Preferred knowledge of systems JD Edwards 9.2, DSI, GSA, SupplyFlex, ComplianceWire, TrackWise, 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 $80,000 to $90,000 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 Should Join Catalent :

Awesome employee activities : Movie Day, Monthly Birthday Celebrations, Friday Bagel Breakfast, On-site Fitness Center with machines, on-site yoga and HIIT classes, Sponsored Sports Teams, and several other company-sponsored events that encourages positive employee comradery, which contributes to effectively building positive employee relationships, overall creating a positive work environment.

Environmentally friendly green initiatives with on-site practices as well as regularly participating in Beach Clean-up activities for community engagement.

Defined career path and annual performance review and feedback process. Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.

Several Employee Resource Groups focusing on Diversity and Inclusion.

Competitive salary with bonus potential. Generous 401K match and Paid Time Off accrual. Medical, dental and vision benefits effective day one of employment.

152 hours of PTO + 10 paid holidays.

Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic.

Tuition Reimbursement Let us help you finish your degree or earn a new one!

WellHub program to promote overall physical wellness.

Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories.

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world.