Senior Quality Assurance Supplier Specialist

Senior Quality Assurance Supplier 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.

This 206,878 square-foot facility, located in the Philadelphia area is Catalent’s global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. Packaging can be configured to hold a single product, or multiple products as determined by study requirements. We offer manual patient kit assembly along with semi-automated and automated wallet sealing and high-speed automated carding to meet the needs of studies of all sizes. For temperature sensitive products and those with minimal to zero allowable time out of environment, we can perform secondary packaging in refrigerated and frozen packaging rooms or over dry ice depending upon your project needs. Using our Clinicopia global labeling system with its multi-lingual label phrase library we can design single panel, booklet labels or our unique Peel-ID™ safe storage labels for your studies. Single panel and Peel-ID™ safe storage labels can be conveniently reviewed and approved online via our Fusion portal before being printed and inspected at our facilities.

Catalent Pharma Solutions in Philadelphia, PA is hiring a Senior Quality Assurance Supplier Specialist. This position reports to the QA Manager. The Senior QA Supplier Specialist is responsible for the creation and maintenance of clinical and commercial specifications related to Catalent-procured packaging components, labels, and stock materials and customer-requested specifications where applicable. The Sr. QA Supplier Specialist will also initiate the supplier complaint process based on incoming inspection outcomes and will review supplier quality complaint responses to assure adequate investigations and corrective/preventive actions. The Sr. QA Supplier Specialist will assist with data gathering for supplier quality metrics trending and supplier quality audits, oversee special projects related to specification management, and identify and implement opportunities to improve processes related to these areas.

This is a full-time, salaried role on-site. This is on 1st shift. The core hours are Monday – Friday, 8am-5pm.

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:

• Collaborates with Project Management to understand and incorporate client expectations in creation and update of commercial specifications
• Partners with Packaging Engineering to ensure critical quality attributes and pertinent requirements are included in clinical specifications for Catalent-produced materials and commercial specifications (if applicable)
• Partners with Production personnel to ensure packaging component attributes that affect the packaging process are appropriately incorporated into specifications
• Initiates supplier quality complaints and engages with suppliers (through partnership with the Procurement department) to ensure adequate investigations and corrective/preventive actions
• Drives and influences timely completion of supplier quality complaints as well as timely review and approval of supplier responses.
• Assists with data gathering activities to support supplier quality metrics trending and supplier quality audits. 
• Identifies and implements operating efficiencies to continuously improve and promote compliance for the clinical and commercial specification process
• All other duties as assigned

The Candidate:

• Requires a Bachelors Degree with at least two years of relevant experience, or Associates degree with at least four years of experience
• Strongly preferred degree in Regulatory Affairs, Biotechnology, Manufacturing, Operations, Supply Chain, Engineering or related discipline
• Proven track record of authoring technical specifications or procedures/work instructions in a regulated field – pharma, medical device, food, etc
• Proven experience with deviation/non-conformance investigations
• Experience working on continuous improvement activities in partnership with other functions (e.g. Production, Validation, etc.) is a plus
• Good computer skills required; Knowledge of MS Office, Trackwise and Controlled Document Management systems are a plus
• Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds

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 of PTO + 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 [email protected]. 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 [email protected] for us to investigate with local authorities.

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