Quality Assurance Associate - Analytical Data Review

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 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.

This individual is responsible to provide QA support to the Analytical Development and Quality Control Units of a Contract Research/Manufacturing Organization, performing analytical method development and review of data generated as part of in-process and release testing of biopharmaceuticals.

Key Responsibilities include but are not limited to:

• Maintain and administer quality systems including document management, investigation/deviations, CAPA tracking, risk management, quality metric tracking, training and other quality systems
• Interface and communicate with the Client, Analytical Development teams, Technology Transfer group and the BMP Manufacturing departments in meeting project timelines, providing deliverables and resolving issues
• Perform quality review of Analytical Development documentation including raw data, test methods, protocols and executed method qualification reports.
• Support external client audits
• Perform periodic walk through audits of Analytical Development and Quality Control laboratories
• Implement continuous improvement initiatives
• Provide quality oversight of process and analytical method development in an R&D setting for client projects
• Provide quality oversight in compliance with GMPs for Quality Control testing of clinical product
• Support the Investigation and Deviation systems for tracking statuses, follow-up, and liaison with applicable department investigation writers to ensure their complete and timely resolution
• Support the CAPA Tracking System and track the timely completion and extension of commitments.
• Develop, administer and track training of the Pre-Clinical Services group
• Review and approve release and stability data, analytical testing protocols/data/reports, analytical method qualification
• Conduct review of demonstration batch documentation for accuracy and completeness, documenting deviations and/or failure investigations as appropriate
• Maintain databases and systems used for tracking various activities
• Generate, revise and review Pre-Clinical Services Standard Operating Procedures (SOPs) and other documentation as needed.
• Support regulatory (FDA, EMA) and client audits/inspections of Paragon
• Work independently under general supervision to meet company goals
• Continually evaluate systems and procedures for improvement for efficiency and compliance to applicable regulatory requirements and standards
• Other duties supporting the QA function within the Pre-Clinical Services Department

Experience & Education:

• Minimum of a B.S. in a Life Sciences discipline
• +8 years' experience within the biologic, biopharmaceutical, or regulated pharmaceutical industry
• +6 years' experience in Quality Assurance/Quality Control function reviewing Analytical testing data OR as an Analytical Chemist with some documentation review.
• Familiarity with Good Manufacturing Practices (GMPs), 21 CFR 210/211/600s, USP and ICH Guidelines
• Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks
• Exposure to Lean Operational Excellence highly desirable

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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