Supplier Quality Specialist

Supplier Quality Assurance Specialist

Position Summary

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.

Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture.  The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for stand-alone and integrated biologics projects.

Catalent Pharma Solutions is hiring a Supplier Quality Specialist. The role will see you as an integral member of the Quality Network. 

This is a full-time, on-site salary position. This position can be located at our Kansas City, Philadelphia or San Diego sites.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. 

The Role:

• Manage the approved supplier list for Global Comparator, Depot and network site programs.
• Plan, conduct, review and report supplier site and questionnaire audits including third-party and outsourced audits for new and existing domestic and international suppliers in line with Network procedures.
• Ensure corrective action activities associated with all audit observations are agreed and completed in a timely manner.
• Complete and assist in completion of supplier quality agreements, supplier audits, (questionnaire and site), risk assessments, risk control plans, license review, change controls, actions and follow-up’s.
• Ensure supplier records are current for all supplier approval documentation including audits, assessments, and quality agreements.
• Evaluate and manage new supplier requests through to completion
• Perform impact assessments and execute action plans for supplier change notifications (i.e. facility change, supplier change controls)

The Candidate:

• A bachelor’s degree in a scientific or engineering discipline with at least two years of experience in pharmaceutical quality, or an equivalent combination of education and experience (e.g. High School Diploma or General Education Diploma with five years’ experience in Quality Auditing).
• Prior supplier auditing experience and experience in writing supplier audit reports, certified auditor or lead auditor credentials are preferred.
• Experience and sound knowledge of GMP/GDP/GCP regulations, especially those related to comparator sourcing, wholesaler licensing, third party storage and distribution preferred.
• Prior experience in JDE and Trackwise systems preferred
• Ability to work independently with strong goal orientation and sense of responsibility.
• Strong process improvement mindset, strategic business perspective and critical thinking capability
• Physical Requirements: On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch, or crawl; talk and hear, smell and lift up to 40 pounds. Specific vision requirements include reading of written documents, visual inspection of materials and use of computer monitor screen frequently

Why you should join Catalent:

• Defined career path and annual performance review and feedback process 
• Diverse, inclusive culture 
• Positive working environment focusing on continually improving processes to remain innovative
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 
• 152 Hours + 8 paid holidays
• Several Employee Resource Groups focusing on D&I
• Dynamic, fast-paced work environment
• Community engagement and green initiatives 
• Generous 401K match 
• Company match on donations to organizations
• Medical, dental and vision benefits effective day one of employment 
• Tuition Reimbursement – Let us help you finish your degree or start a new degree!
• WellHub program to promote overall physical wellness 
• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories

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. 

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.

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