Specialist, QA OTF

Specialist, QA OTF

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.

Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location. The campus is close to Washington, DC’s I-270 Technology Corridor, top universities, and government agencies.

The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse.

The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing.

Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines.

Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love.  Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives.

The Specialist, QA is responsible for providing Quality Assurance support for GMP Manufacturing of master/working cell banks, biological bulk drug substance and finished drug product to be used for human consumption. Responsibilities include providing QA On-The-Floor (OTF) oversight of manufacturing including observing manufacturing operations and reviewing documentation for compliance. Continuously monitor systems and procedures to ensure compliance with applicable regulatory and industry standards, quality improvements, and efficiency for phase appropriate GMP manufacture of biological products. 

This is a full-time on-site position, 7am-7pm 2-2-3 rotation

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:

• Provides dedicated QA quality floor oversight of GMP operations for the manufacture of master/working cell banks, bulk drug substance and/or final drug product – 75% of day is spent on the floor.
• Performs QA on the Floor activities supporting client projects, including room release, observing critical processes, reviewing batch documentation in real time, cleaning documentation, logbooks and resolving issues that occur during manufacturing.
• Partner with Manufacturing and other support teams
• Perform Acceptable Quality Limit (AQL) visual inspection of drug product
• Review and approve batch documents for media and buffer prep solutions
• Generate or revise GMP documentation such as Standard Operating Procedures, Master Batch Record review and SMP’s
• Compile deviations as required when observed on the floor, and move to completion within the required time frame
• Provides dedicated QA quality floor oversight of GMP operations for the manufacture of master/working cell banks, bulk drug substance and/or final drug product – 75% of day is spent on the floor.
• Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and Good Documentation Practices
• Make solid quality decisions with limited oversight
• Identify and implement and continuous improvement initiatives 
• Participate in site and corporate quality and process improvement initiatives.
• Guides personnel indirectly and