Senior Specialist, QC Compliance

Catalent's Winchester, Kentucky location is the flagship US manufacturing location for large scale complex controlled release (CR) oral dose forms, with integrated analytical and development services. With 20 years of expertise in product development, technology transfers and commercial manufacturing, and roots in industry leading Glatt technology. This site offers newly installed Fluid Beds, expanded analytical labs, and an advanced open facility design that provides flexibility in supporting the requirements of any new customer program.

Position Summary:

The Senior Specialist, QC Compliance is responsible for making quality decisions for LIRs/deviations within quality control and disposition/release of Raw Materials for use in production. Serves as analytical and technical QA resident expert for Quality Control. Develops and supports departmental strategic goals for Catalent to assure the highest quality standards and regulatory compliance.

The Senior Specialist, QC Compliance provides world class customer service, with the highest levels of integrity, focused on quality and compliance in partnership with Catalent-WIN customers and internal organizations. This position serves as a representative for their client(s) within the Catalent-WIN site.

The Role:

• Oversee Raw Material Quality Control Data review and approval for release.
  
• Raw Material Planning and Coordination with QC Raw Materials Manager.
  
• Audit all related QC files and materials to verify in a current status
  
• Approve any required Hold/Reject transactions for raw materials
  
• Release Raw Materials for manufacturing use. This could include after hours, weekend call-ins and limited travel to off-site warehouse.
  
• Quality review for API's, excipients for Quality Control laboratory as needed
  
• Oversee and approve quality decisions involved in LIRs/Deviations within Quality Control Department
  
• Assist in the review, revision and /or writing of SOPs/documents related to position
  
• Other duties as assigned
  

The Candidate:

Education:

• Bachelor of Science in pharmaceutical applicable field; examples may include Science, Biology, Chemistry, or Engineering.
  

Experience:

• Bachelor's Degree in Science, Biology or Chemistry, Work Experience - 7+ years in quality or regulated industry OR
  
• Master's Degree in Science, Biology or Chemistry, Working Experience - 5+ years in quality or regulated industry OR
  
• Working Experience - 15+ years in quality or regulated industry
  

Knowledge/Skills Requirements:

• Must be able to demonstrate successful communication skills at all levels of internal and client organizations and regulatory agencies. Effectively maintaining these partnerships to alignment and action.
  

Physical Requirements:

• Ability to enter manufacturing areas requiring full gowning (e.g., ability to bend, kneel, and stand on feet for long periods of time in a clean room or warehouse area).
  
• Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening.
  
• Occasional bending, grasping, carrying, stooping, kneeling, crouching
  
• Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 35 pounds.
  
• Individual may be required to site for extended periods.
  
• Specific vision requirements include reading of written documents and use of computer monitor screen frequently.
  

Catalent's standard leadership competencies

• Leads with Integrity and Respect
  
• Delivers Results
  
• Demonstrates Business Acumen
  
• Fosters Collaboration and Teamwork
  
• Champions Change
  
• Engages and Inspires
  
• Coaches and Develops
  

Why you should join Catalent:

• Medical, Dental, Vision and 401K are all offered from day one of employment
  
• 19 days of paid time off annually
  
• Potential for career growth within an expanding team
  
• Defined career path and annual performance review and feedback process
  

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 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.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

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 DisabilityAccommodations@catalent.com . 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 spam@catalent.com for us to investigate with local authorities.