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Manufacturing Quality Associate (QA) II

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.

The Research Triangle Park (RTP) facility is home to Catalent's Inhalation franchise including product development, clinical and commercial manufacturing for pMDI, DPI and Nasal Sprays.

Catalent Pharma Solutions in Morrisville, NC is hiring a Manufacturing QA Associate II. The Manufacturing QA Associate II supports manufacturing facility inspection operations. Candidate should have prior Good Manufacturing Practice (GMP) inspection experience within a pharmaceutical manufacturing facility or equivalent. Candidate must be detail oriented in a fast-paced multi-task environment with good oral and written communication skills and have the ability to interact with all levels of management and all departments. The facility operates 24/5 with scheduled weekend work anticipated.

This is a full-time 3rd shift hourly position with 10% shift differential. The core hours are Sunday – Thursday, 10:00PM – 6:30AM

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:

+ Provide QA support to manufacturing for clinical and commercial batches in compounding, filling and packaging operations

+ Performs Line Clearances, equipment releases, AQL inspections and real-time batch record review on the shop floor

+ Liaise with manufacturing and peers. Perform material releases. Place non-conforming material and product On Hold as required

+ Assist with batch investigations and final review and approval of executed batch records as required and resolve identified discrepancies and reported non-conformances

+ Perform classification of non-conforming investigations and closure of events

+ Provide QA support for non-conforming investigations. Support release of finished product from 3PL for shipment as required

+ Rotational weekend work to support manufacturing as required

+ All other duties as assigned

The Candidate:

+ Candidate must have a high school diploma/GED minimum. Associates/Bachelor’s preferred

+ Must have at least two (2) years of relevant experience working in the pharmaceutical industry in Quality Assurance, Compliance, or Manufacturing

+ Candidate must have foundational understanding of compliance, regulations, and inspection techniques and thorough knowledge of cGMPs, ability to evaluate facilities records, processes, procedures, and practices for conformance to these requirements

+ **Physical requirements:** Individual must be accessible to manufacturing areas and office staff and able to use required office equipment. Specific vision requirement includes reading of written documents and use of computer monitor screen frequently. Individual may be required to sit, stand, and walk regularly and lift up to 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 + 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 [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 (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .