Operations Compliance Specialist CSS

Operations Compliance Specialist

Position Summary

• Shift: Monday-Friday 8am-4pm
• 100% on-site

Catalent Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop manufacture and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma biotech and consumer health customers supporting product development launch and full life-cycle supply. With time-tested experience in development sciences delivery technologies and multi-modality manufacturing Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

The Operations Compliance Specialistprovides technical and regulatory expertise to the investigation and deviation management process to ensure patient safety regulatory compliance and inspection readiness.

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 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 event
• 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

The candidate:

• High School Diploma required
• Bachelors Degree desired or equivalent experience in the pharmaceutics 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)
• Lean Six Sigma SPC experience (1 year preferred)
• Excellent oral and written communication skills
• Proactive problem-solving and analytical skills
• Ability to simultaneously work on several projects with the flexibility to reprioritize in a minimum amount of time

Why you should join Catalent:

• Competitive medical benefits and 401K
• 152 hours PTO 8 Paid Holidays
• Dynamic fast-paced work environment
• Opportunity to work on Continuous Improvement Processes

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability you may submit your request by sending an email and confirming your request for an accommodation and include the job number title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment bank details photocopies of identification social security number or other highly sensitive personal information during the offer process and we NEVER do so via email or social media. If you receive any such request DO NOT respond it is a fraudulent request. Please forward such requests to for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.