Data Reviewer - Quality Control Microbiology

Paragon Gene Therapy, now a part of Catalent, hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with 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.

Paragon Gene Therapy, in Rockville, Gaithersburg, Baltimore & Harmans, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses.

The Data Reviewer will perform detailed data review for microbiological test results on assays such as Bioburden, endotoxin, Environmental Monitoring and Clean Utility testing data, generated by the QC Microbiology department, for compliance with cGMP, internal SOPs and Specifications to support production, stability studies and lab operation.

Key Responsibilities include but are not limited to:

• Review release and stability data, lab equipment calibration records and log-books and other review function as needed
• Perform detailed data review for microbiological test results generated by contract testing labs to assure their correctness and accuracy
• Receive Batch Records from other departments
• Receive and organize completed test results
• Work with analysts to complete any corrections to data notebooks
• Compile data results in accordance to SOPs and QC best practices
• Maintain and update relevant SOPs for data review and reporting as needed
• Ensure that suitable written records and work undertaken are kept in accord with cGMP and company procedures
• Receive and organize completed Test Records
• Pairing of completed Test Records with Batch Records
• Respond to other department inquiries regarding status of results

Experience & Education:

• Associates degree required; Bachelor degree preferred with 2 or more years of experience reviewing Quality Control data for cGMP compliance.
• Prior experience in reviewing microbiological assays and environmental monitoring data in a cGMP Quality Control lab required
• Prior experience in performing microbiological assays and environmental monitoring in a cGMP Quality Control lab is a plus.
• Strong attention to detail and strong organizational skills

Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

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