QC Associate Data Reviewer

The QC Associate Data Reviewer will review laboratory data generated by QC Analysts per GMP and GDP expectations and standards and with a high attention to detail. This position requires both to work independently and with the team to perform routine and non-routine data review.

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:

• Perform routine review of Bioburden and Endotoxin samples, identify errors, escalate potential problems or deviations, request corrections from QC Analysts.
• Review and Approve samples on GLIMS.
• Support both routine and non-routine (priority/STAT) data packets for review.
• Perform data review with GDP/GMP understanding and escalate any discrepancies from those expectations.
• Facilitate error corrections and provide assistance in addressing corrections as needed for QC Analysts, MFG Associates, etc.
• Ensure organization of data packets are maintained.
• Identify and escalate areas for systemic or procedural improvements pertaining to data review.
• Maintain the Document Storage Room in an Audit Readiness state.

The candidate:

• Bachelor’s degree in the Life Sciences (e.g., Chemistry, Biochemistry, or closely related field) or Data Systems with 0-2 years of experience.
• Associate’s Degree in the Life Sciences (e.g., Chemistry, Biochemistry, or closely related field), or Data Systems with 2 – 3 years of experience working in a cGMP QC laboratory.
• Experience working in cGMP Quality Control
• Preferred experience in cGMP environment and experience with Quality Tools such as SPC and Root Cause Analysis, USP, HACCP, and Technical writing skills.
• Demonstrate strong scientific understanding of analytical and microbiological methods or chemical methods and their relation to natural processes.

The anticipated salary range for this position in Maryland is $58,240 to $80,080 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.

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 individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employ