Operations Quality Specialist

Operations Quality Specialist

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.

Catalent Pharma Solutions is hiring an Operations Quality Specialist. The Operations Quality Specialist ensures all the products and services offered by Catalent are of the highest quality in terms of satisfaction, predictability, and sustainability.

Shift: Monday-Thursday 12:00pm-10:30pm. 2nd shift. ​

This position is 100% on-site at the Malvern site.

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 and approve all batch records prior to production to ensure that they conform to requirements of cGMP and SOP requirements. Ensure that any changes are performed according to procedures.

• Monitor schedule for production priorities.

• Communicate with other functions to resolve inconsistencies with proper recording and completion of the batch record and associated documentation.

• Communications may include educating other functions to ensure compliance to regulations, procedures, and client requirements.

• Ensure timely release of batch. Release batch within MRP System. Review and release raw materials.

• Record and track errors and right-first time to maintain departmental metrics.

• Archive batch documents onto shared drive and within archive room.

• Ensure that responsibilities are completed efficiently while maintaining Quality.

• Review operations investigations.

• Edit SOPs applicable to operations.

• All other duties as assigned.

The Candidate 

• Required a High School with two years’ experience in a regulated industry or;

• Bachelor's Degree highly preferred.

• Good Computer Skills. Knowledge of MS Office and programs associated with the position desired.

• Good knowledge of the application of FDA cGMP’s is required.

• Good math skills preferred.

• Individual may be required to sit, stand, walk regularly and occasionally lift up to 40 pounds.

Why You Should Join Catalent 

• Competitive medical benefits and 401K 

• 152 hours of PTO + 8 Paid Holidays 

• Dynamic, fast-paced work environment 

• Opportunity to work on Continuous Improvement Processes

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 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