Change Control Associate

Catalent • Durham, NC

4d • Onsite

About The Position

Change Control Associate
Position Summary:
Work Schedule: Monday - Friday, 8:00am to 5:00pm
100% on-site
The Morrisville (MSV) facility is Catalent’s center of excellence for nasal product development and manufacturing, providing end‑to‑end services from early formulation through clinical and commercial production. The site offers comprehensive nasal development capabilities, including analytical support, device selection, spray characterization, and both clinical and commercial scale for unit‑dose, bi‑dose, and multidose nasal products. The Morrisville site also provides development services for dry powder (DPI) and liquid pulmonary products including formulation development and optimization, method services and analytical testing.
The Change Control Associate is responsible for reviewing change controls for initial and final approval as well as associated change actions, recommending changes or improvements to change control process, providing SME feedback to owners on change control content or process. The individual will function as a resource person for other individuals at the site for the change control process and is able to perform routine auditing of change control processes and procedures and lead CCRB and supporting meetings with support.

Requirements

• Must have a Bachelor’s Degree and a minimum of 2 year of related experience OR Associate’s Degree and a minimum of 5 years of related experience OR equivalent of related education, training and experience
• Must be proficient in MS Office
• Knowledge of cGMP, GLP, ICH, and USP regulations or guidelines is required
• Individual may be required to sit (up to eight hours), stand (up to five hours), walk (up to three hours) regularly and occasionally lift 0-15 pounds

Nice To Haves

• Prior experience with commercial manufacturing is highly desired, experience with early through late-stage clinical trial material manufacturing experience is a plus

Responsibilities

• Assess, author, and/or approve change control
• Create and revise standard operating procedures for change control and QA systems; revisions may be related to process improvements, customer requests and/or audit observations
• Represent the Quality Department in Change Control activities associated with manufacturing equipment, processes, documentation and products
• Compile and maintain metrics related to change control and Documentation Systems
• Interface with Engineering and Operations to ensure transfer to Production of new products are in accordance with approved data
• Work with customer and internal teams to accurately maintain and archive company documentation to achieve quality deliverables
• Other duties as assigned

Benefits

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• 152 hours of PTO + 8 paid holidays
• Generous 401K match
• Medical, dental and vision benefits
• Tuition Reimbursement - Let us help you finish your degree or start a new degree!
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees