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Catalent · 1 day ago

Operations Compliance Specialist

San Diego, CA

Full-time

Onsite

Entry, Mid Level

$80K/yr - $90K/yr

2+ years exp

Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO), and they are seeking an Operations Compliance Specialist. This role ensures patient safety and regulatory compliance by leading investigations, managing deviations, and facilitating problem-solving sessions while leveraging Lean and Six Sigma tools.

BiotechnologyHealth CareManufacturingPharmaceutical

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

Qualification

Lean Six SigmaPharmaceutical PackagingTechnical WritingStandard Operating ProceduresRoot Cause AnalysisCommunication SkillsProblem SolvingTeam CollaborationFlexibility

Required

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

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

Preferred

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

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.

Company

Catalent

Catalent - Blow-Fill-Seal Sterile CDMO Business is focusing on complex clinical to commercial stage formulation and manufacturing. It is a sub-organization of Catalent Pharma Solutions.

Founded in 2007

Somerset, New Jersey, USA

10001+ employees