Operations Compliance Specialist

Catalent•San Diego, CA

18h•$80,000 - $90,000•Onsite

About The Position

Operations Compliance Specialist Position Summary: Work Schedule: Monday-Friday, core hours 8am-4:30pm 100% on-site (San Diego) 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.

Requirements

High School Diploma/GED required.
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
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
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

Nice To Haves

Bachelor of Science in Engineering, Pharmaceutical Sciences, or a related field is highly preferred.
Lean Six Sigma certification is highly desirable
Preferred knowledge of systems – JD Edwards 9.2, DSI, GSA, SupplyFlex, ComplianceWire, TrackWise, EDMS, etc.

Responsibilities

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

Benefits

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.