Specialist, QA OTF

Specialist, QA OTF

Position Summary

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.

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.

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 position is Night Shift 7PM-7AM 2-2-3 schedule and is 100% on site at BWI/Harmans, MD facility.

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.

• 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.

• Guides personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices.

• Other duties as assigned.

The Candidate

• Masters’ degree in a Scientific, Engineering or Biotech field; OR Bachelor’s degree in a Scientific, Engineering or Biotech field with minimum 2 years’ experience in Quality Assurance/Quality Control/Manufacturing within biologics, biopharmaceuticals, or a regulated industry.

• Familiarity with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs.

• Knowledgeable and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification and fill/finish.

• Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks.  

• Familiarity with electronic systems, including developing and producing reports using Microsoft products.  LIMS, Master Control and Trackwise knowledge preferred. 

• Able to work in a team setting and independently, under supervision.

• Requires the ability to produce results in a fast-paced environment to meet client deadlines.