Catalent, Inc.
pharmaceutical
OperationsComplianceSpecialist
“Operations Compliance Specialist at Catalent, Inc.. Skills: investigations, deviations, complaints, Root Cause Analysis (RCA), CAPAs, SOPs, technical writing. ensures patient safety, regulatory compliance, and inspection readiness by leading investigations and managing deviations and complaints. facilitates Rapid Response Team fact-gathering”
What You'll Achieve.
ensures patient safety, regulatory compliance, and inspection readiness; prevent recurrence of quality events; strengthen operational standards; ensure that reporting is performed on time and investigations/complaints are addressed in a timely manner
Industry & Context.
leads cross-functional problem-solving sessions; Facilitate cross-functional problem-solving events.; Deploy industry-standard lean and six sigma tools to address the root causes of non-conforming quality events; drives root cause analysis (RCA)
100% on-site (San Diego), able to perform duties which include standing, walking, sitting frequently and significant amount of use of office equipment and computers, keyboards, and writing by, Must be able to lift up to 35lbs and work in temperature-controlled freezers/fridges occasionally
What They're Looking For.
Must Have
Bachelor's degree required, preferably in Science, Engineering, Pharmaceutical Sciences, or a related field., 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, knowledge of Microsoft Office software and query-based systems activities (e. g. , Pivot Tables, VLOOKUP’s, Excel Formulas, building presentations in PowerPoint, 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, able to perform duties which include standing, walking, sitting frequently and significant amount of use of office equipment and computers, keyboards, and writing by, Must be able to lift up to 35lbs and work in temperature-controlled freezers/fridges occasionally
Nice to Have
Lean Six Sigma certification and experience is highly desirable, Preferred knowledge of systems – JD Edwards 9. 2, DSI, GSA, SupplyFlex, ComplianceWire, TrackWise, EDMS, etc.
What You'll Do.
ensures patient safety
regulatory compliance
and inspection readiness by leading investigations and managing deviations and complaints
facilitates Rapid Response Team fact-gathering
authors clear and comprehensive investigation reports
proposes effective Corrective and Preventive Actions (CAPAs) to prevent recurrence of quality events
drives root cause analysis (RCA)
leads cross-functional problem-solving sessions
develops Standard Operating Procedures (SOPs) and work instructions to strengthen operational standards
Participate in and facilitate Rapid Response Team fact gathering
Write Investigation reports
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
How You'll Work.
Team & Collaboration
leads cross-functional problem-solving sessions; Facilitate cross-functional problem-solving events.; Communicates clearly with internal and external clients, both verbal and written.; communicate effectively with internal and external customers, peers and managers
Communication Scope
Communicates clearly with internal and external clients, both verbal and written.; communicate effectively with internal and external customers, peers and managers
Process & Methodology
Manage timelines for investigations/complaints to ensure that reporting is performed on time and investigations/complaints are addressed in a timely manner, Ability to simultaneously work on several projects with the flexibility to reprioritize in a minimum amount of time.
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