Operational Compliance Specialist
About The Position
The Operational Compliance Specialist provides technical and regulatory expertise to the investigation and deviation management process to ensure patient safety, regulatory compliance and inspection readiness. Catalent’s Kansas City (KCM) facility is a premier site for integrated drug development, manufacturing, and clinical supply services, supporting a wide range of pharmaceutical and biotech products. With cutting-edge technologies and a collaborative work environment, it offers exciting opportunities for professionals across all functions—from science and engineering to operations and logistics.
Requirements
- HS Diploma or GED required
- Bachelor’s Degree desired or equivalent experience in the pharmaceutical industry
- Knowledge (minimum of 2 years) of pharmaceutical packaging and distribution processes, Standard Operating Procedures (SOPs) and GxPs
- Technical writing such as validation reports, engineering documents, controlled documents (SOPs, BRs, WIs) in a GxP environment (minimum of 1 year)
- Proactive problem-solving and analytical skills
- Self-motivated, disciplined, focused, work well under pressure and be able to prioritize work
- Ability to simultaneously work on several projects with the flexibility to reprioritize in a minimum amount of time
Nice To Haves
- Lean, Six Sigma, SPC experience (1 year preferred)
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
- Deploy industry-standard lean and six sigma tools to address the root causes of non-conforming quality events
- Facilitate cross-functional problem-solving events
- Author SOPs and work instructions
- Review investigation documentation for OOS, OOT 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
- Communicates clearly with internal and external clients, both verbal and written
- Other duties assigned
Benefits
- Day-one benefits: medical, dental, vision
- 401(k) match
- tuition reimbursement
- wellness perks
- Paid time off: 152 hours + 8 holidays
- Discounts from 900+ merchants via Perkspot
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
