Quality Systems Specialist - External Audit

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 role is responsible for supporting the quality systems attributes associated with client audits, through audit preparation, hosting and backroom support. Additional responsibilities include ownership and driving of investigation/deviation, CAPA, change control, risk management, and other quality system functions, directly related to client audit. Works in a fast-paced environment supporting the quality assurance/quality control departments of a CMO for Phase I/II GMP manufacturing of biologic bulk drug substance and sterile finished drug product.

Extended work and/or weekend work may be required at times.

Key Responsibilities include but are not limited to:

• Responsible for administrating support for client audits/inspections of Paragon.
• Audit support may require leading back rooms, fulfilling client requests, and/or other audit supporting administrative responsibilities.
• Responsible for being a liaison with applicable departments to ensure their complete and timely resolution of audit items.
• Responsible for understanding batch documentation for applicable to client audits focused points.
• Maintains databases and systems used for tracking various GMP manufacturing associated audit support activities
• Assists with the generation and/or revision of GMP documentation such as standard operating procedures.
• Assists with the generation of audit report responses, technical writer for GMP systems.
• Works closely with manufacturing, Facilities and Quality Control staff to resolve quality issues regarding the facilities and product manufactured
• Work closely with other departments at Paragon and offer assistance as needed
• Continually evaluate systems and procedures for improvement for efficiency while ensuring compliance to applicable regulatory requirements and standards

Experience & Education:

• B.S. in a Life Sciences discipline and 6+ years of relevant experience - OR - M.S. in a Life Sciences discipline and 4+ years of relevant experience
• Experience within the biologic, pharmaceutical or medical device industry performing direct hands-on work in a Quality Aurance/Quality Control function with a strong familiarity of general GMP documentation
• Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks
• Familiarity with Good Manufacturing Practices (GMPs) and 21 CFR
• Familiarity with electronic systems, including Microsoft Access and Excel
• Experience supporting Federal government contracts is a plus
• ASQ CQA (American Society of Quality Certified Quality Auditor) 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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