Quality Assurance Specialist, Commercial Manufacturing

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.

Catalent’s Greenville, N.C. facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing, and packaging. This state-of-the-art facility has had over $100M of investments in recent years and features fit-for-scale capacity with potent handling capabilities, ideal for orphan or targeted drug development.

Second Shift: Monday – Thursday, 4 PM – 2:30 AM

The Quality Assurance Specialist will perform established routine and non-routine Quality Assurance tasks with minimal supervision in support of internal non-commercial clients, external clients and/or commercial processes and projects as assigned. The Quality Assurance Specialist will perform batch record review and on the floor Quality Assurance commercial manufacturing support.

Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. 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

• Review quality documentation including but not limited to review and release of batch records and/or product, release of equipment, room set up, room clearance, initial documentation of unplanned events as appropriate.

• Ensure integrity of data through accurate transactions, documentation, and tracking of all cGMP activities.

• Provide broad advocacy for the continued improvement of quality standards and the development and maintenance of a quality culture across the organization.

• Support the development of a climate of quality and safety within the teams, by identifying and monitoring quality and safety standard. Perform gemba walks of manufacturing and packaging areas. Work to create an environment of open communication, participation, and information-sharing within and between teams within quality assurance and throughout the facility.

• Ensure compliance to all compendial, internal and client-specific requirements (i.e. SOPs, Quality Agreements, General and Informational Chapters in multiple compendia as applicable).

• Provide assistance to manufacturing with appropriate quality oversight. Provide real-time support activities for manufacturing and packaging.

• Escalate unplanned events and issues, providing immediate notification to QA Management, supporting and providing guidance to manufacturing staff. Demonstrate knowledge of root cause analysis techniques to support manufacturing investigation teams.

• Remain proficient and knowledgeable within respective field of operation in accordance with job responsibility and function, able to troubleshoot process, system, material and technique-related issues. Become proficient in ERP System, Document Management System and TrackWise.

• Other duties as assigned.

The Candidate

• Bachelor’s degree with 4+ years of professional experience in the pharmaceutical industry and 2 years in a direct QA role required OR

• Associate degree with 5+ years of professional experience in the pharmaceutical industry and 3 years in a direct QA role required.

• Must have experience with batch record review and on the floor Quality Assurance commercial manufacturing support.

• Position requires the capacity to handle and manipulate objects using hands and arms.

• Individual may be required to sit, stand, walk regularly and occasionally lift 0-20 pounds.

Why You Should Join Catalent

• Tuition Reimbursement – Let us help you finish your degree or earn a new one!

• WellHub program to promote overall physical wellness.

• 152 hours of PTO + 8 paid holidays.

• Medical, dental and vision benefits effective day one of employment.

• Defined career path and annual performance review and feedback process.

• Diverse, inclusive culture. Several Employee Resource Groups focusing on D&I. Community engagement and green initiatives.

• Dynamic, fast-paced work environment.

• 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.

• 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) .