Senior Specialist, Client Support

The Senior Specialist, QA Client Support is responsible for providing QA support to Client Projects from start to finish for GMP Manufacturing of master/working cell banks, biological bulk drug substance and finished drug product.  The general specialist is responsible for ensuring compliance to regulatory, GMP and industry standards. This role is responsible for review of quality documents. Responsibilities include tracking and reviewing, specifications, master batch records, change requests, deviations and failure investigations as well overall support for client QA and release of manufactured material.

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.

The role:

• Provides QA support to client projects and client interactions & meetings, as needed. 
• Supports Clinical and Commercial QA activities, including initial process development and non-clinical batch production.
• Supports GMP departments in reviewing and approving deviations and failure investigations, including root cause analysis, evaluating product/facility impacts, and evaluating effective corrective and preventive actions (CAPAs)
• Performs risk analysis and mitigation, using available tools such as FMEA, when needed.
• Maintains databases and systems used for tracking various GMP manufacturing associated support activities and records
• Assists with the review and approval of GMP documentation such as Standard Operating Procedures
• Support regulatory (i.e. FDA, EMA) and client audits/inspections
• Assists with internal audits of GMP systems and facilities

The candidate:

• Masters’ degree in a Scientific, Engineering or Biotech field with 2 – 4 years’ experience in Quality Assurance/Quality Control within biologics, biopharmaceuticals, or a regulated industry.
• Bachelor’s degree in a Scientific, Engineering or Biotech field with 4 - 6 years’ experience in Quality Assurance/Quality Control within biologics, biopharmaceuticals, or a regulated industry.
• Knowledge within 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.
• Familiarity with electronic systems, including developing and producing reports using Microsoft products. LIMS, and Trackwise knowledge preferred. 
• Creative individual with excellent analytical, trouble shooting, and decision-making skills

The anticipated salary range for this position in Maryland is $93,280 to $128,260 plus an annual bonus target. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.

Why you should join Catalent:

• Competitive medical benefits and 401K
• 152 hours 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.

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