Manufacturing Quality Associate

Position Summary:

Catalent Pharma Solutions is hiring a Manufacturing Quality Associate for the Morrisville, NC site. The Manufacturing Quality Associate must be familiar with applicable GMP. This individual will be responsible for evaluating the compliance of manufacturing and analytical documents such as test methods, batch records, stability, and release data, etc. with supervision. This individual will function as a primary role within the QA department and must demonstrate excellent communication, critical thinking, and organizational skills.

This is a full-time role position: 3rd Shift  10pm – 6:23am

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. 

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

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.
• Perform Line Clearances, equipment releases, AQL inspections and real-time batch record review on the shop floor.
• Liaise with manufacturing and peers.
• Assist in material release – warehouse.
• Assist in release of product from 3PL.
• Place non-conforming material and product On Hold as required.
• Assist with batch investigations and perform final review and approval of executed batch records as required and resolve identified discrepancies and reported non-conformances. 
• Rotational weekend work to support manufacturing as required.

The Candidate

• Requires BA or BS in Chemistry or other related sciences; or combination of education and equivalent work experience.
• Requires thorough knowledge of cGMPs, ability to evaluate facilities records, processes, procedures, and practices for conformance to these requirements. 
• Should have knowledge of current industry expectations of analytical testing requirements for primary and secondary packaging components.
• Understanding of statistical sampling methodologies.
• Ability to organize time for multiple tasks (major projects and daily functions) handle multiple projects and deliver on project timelines with little supervision.
• Function and problem solve independently with some supervision; escalate to area supervision as required.
• Knowledge of cGMP, GLP, ICH, and USP regulations or guidelines for US (FDA) and other regulatory bodies (EU, Health Canada, etc.)
• Individual may be required to sit, stand, walk regularly and occasionally lift 0-50 pounds;

Why you should join Catalent:

• Defined career path and annual performance review and feedback process 
• Diverse, inclusive culture 
• 19 days of PTO 8 paid holidays
• Several Employee Resource Groups focusing on D&I
• Dynamic, fast-paced work environment
• Employee Stock Purchase Program
• 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 
• Competitive salary with bonus potential 
• Community engagement and green initiatives 
• Generous 401K match and Paid Time Off accrual 
• Medical, dental and vision benefits effective day one of employment 
• Tuition Reimbursement – Let us help you finish your degree or earn a new one!
• GymPass program to promote overall physical wellness 
• Perkspot - offers exclusive or private discounts from approximately 900 merchants in a wide array of categories