Quality Specialist, Quality Management Systems

Quality Specialist, Quality Management Systems

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 a Quality Specialist, Quality Management Systems. The Quality Specialist, Quality Management Systems must be flexible and have well-developed organizational skills and have the ability to interact with all levels of personnel. The Quality Specialist, Quality Management Systems must be a self-starter, results oriented individual with ability to articulate, receive, disseminate and analyze data. The Quality Specialist, Quality Management Systems is responsible for assisting in managing the development, implementation and maintenance of quality assurance standards and procedures as well as quality systems to ensure the precision, accuracy and reliability of company products in accordance with quality specifications, government, company and GMP standards

This is a full-time role position: Monday-Friday 8:00am-5:00pm. Salary Role, Onsite

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  

• Lead Document Management site program (hardcopies, EDMS). Interact with other divisions of Catalent in regard to record retention policies and document management and control.

• Leads  the  Training  Program  for GMP  Training,  Procedural  based  training,  and  other  training  need  for  performing tasks. Site administrator for Trackwise, EDMS and ComplianceWire

• Lead the revisions and implementation of Catalent Global standard updates for the site. Lead completion of Annual Product Quality Review documents on schedule, as required. Schedule, prepare for and lead customer audits through response and audit closure.

• Assist in preparing, supporting and closure of the site for inspection by regulatory authorities.

• Develop new procedures, and review and update existing procedures. Represent QA on project teams and other internal forums. Use and extract information from the following systems: EDMS, TrackWise, and ComplianceWire

• Work closely with site on Trackwise compliance and timeliness of responses. Site Pathwise representative. Completion of QMR presentation and minutes

• Reporting of monthly Quality metrics. Lead Supplier program (qualification, requalification, complaints, technical agreements). Lead Internal Audit program. Lead Quality Technical Agreements for the site with client. Manage Iron Mountain and record retention

• Backup for DEA and State Licensing program

• All other duties as assigned; 

The Candidate 

• Required a High School Diploma with Five years of experience working in a regulated environment, such as, food, aero, automotive, pharma.

• Bachelors Degree highly preferred

• Candidate must have computer skills with MS Office and capable of quickly learning other software including EDMS, TrackWise and ComplianceWire.

• Individual may be required to sit, stand, walk regularly and occasionally lift up to 40 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 of PTO + 8 paid holidays

• Several Employee Resource Groups focusing on D&I

• Dynamic, fast-paced work environment

• Community engagement and green initiatives 

• Generous 401K match 

• Medical, dental and vision benefi