Catalent Pharma Solutions

Quality Specialist II, Supplier and Material Management

Position Summary:

Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.

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 in Kansas City, MO is hiring a Quality Specialist II, Supplier and Material Management. The Quality Specialist II, Supplier and Material Management supports the state of regulatory and quality assurance (QA) compliance at the Kansas City Biologics and Early Phase Pharma Manufacturing site through the Supplier Quality Management program. We are a growing team and looking for highly-motivated individuals to be future Quality leaders!

This is a full-time salaried position: Monday – Friday, flexible outside of core business hours 9am-3pm.

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:

• Supplier Management - Aide in the creation of the annual audit schedule and complete supplier assessments in timely fashion.Review completed supplier questionnaires and complete supplier risk assessments to determine frequency of reassessment.Evaluate New Supplier requests and maintain the Approved Supplier List to ensure supplier information is up-to-date and accurate.Identify the need for site level Supplier Quality Agreements, track and initiate their renewal. Ensure that site procedures related to supplier quality management are aligned with global policies

• Act as Subject Matter Expert for the Supplier Trackwise Module

• Manage and write complaint records for suppliers, ensuring proper CAPAs and investigational procedures are completed

• Material Management - Creation of Purchase Specifications.Perform elemental impurity and EU risk assessments, upon request.Manage the assessment of supplier change notifications related to local suppliers. Act as a Material Review Board Member

• External Supplier Audits - Communicate with Catalent Global Supplier team to provide Pre-Audit Data forms to support Global on-site audits

• Provide an active role in the quality oversight of the Pest Control Program and participate in walk-through inspections of local contractor warehouses.

• Support other activities within the quality department, which may include providing compliance metrics for site and corporate management, supporting regulatory inspections, client audits, commercial data reports and other quality or regulatory activities as needed

• All other duties as assigned

The Candidate:

• This position requires either: high school diploma/GED with 5+ years of experience in QA internal/external audits in a GMP environment OR a Bachelor’s degree and one or more years of experience in QA Auditing in a GMP environment

• ASQ Quality Certification highly preferred

• Experience conducting supplier audits is a plus

• Advanced proficiency with Microsoft Word, Excel, and PowerPoint is required. Experience with SharePoint, TrackWise, JD Edwards, EDMS (Electronic Document Management System), or other quality system software preferred

• This position requires the preparation and issuance of reports. The candidate must be comfortable writing concise, logical and grammatically correct audit reports for distribution to the supplier and to Catalent Corporate

• Knowledge of US (FDA), European, and other Good Manufacturing Practices regulatory requirements strongly preferred. The candidate is required to abide by GMP rules and regulations

• Physical requirements: Individual may be required to sit, stand, walk regularly and occasionally lift up to 10 pounds; ability to communicate orally with customers, vendors, and co-workers. Regular use of telephone and email. Hearing, vision, and speaking within normal ranges is essential for normal conversations, to receive ordinary information and to prepare or inspect documents. Good manual dexterity for the use of common office equipment such as computer terminals, calculator, copiers, and fax machines. Good reasoning ability is important. Able to understand and utilize management reports, memos, and other documents to conduct business

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 (https://careers.catalent.com/us/en) 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 (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .