Quality Assurance Associate - Materials Control - 2nd Shift

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 is a 2nd Shift position

The Quality Assurance Associate conducts reviews of GMP documentation associated with materials control (material specifications, receipt inspection forms, inventory records, item request form). Works with Materials Control to quarantine and release all GMP materials in a timely manner and assists Materials Control, as needed, in the receipt of GMP materials - rectify discrepancies, matching vendors' documentation against Paragon requirements (GMP and accounting). Initiates appropriate documentation in a timely manner

Key Responsibilities include but are not limited to:

• Assists with the generation and/or revision of GMP documentation such as Standard Operating Procedures
• Support regulatory and client inspections of Paragon
• Support internal audits of GMP systems and facilities
• Works cross-functionally with Materials Control, Purchasing, Manufacturing, Quality Control and other departments to resolve raw material quality issues and provide assistance when needed
• Continually evaluates Quality and Materials Control processes and procedures to improve efficiency and ensure compliance to appropriate GMPs
• Collaborate with other members of Quality Assurance, including cross training where necessary, for performing duties and tasks in support of Paragon's Quality Systems

Experience & Education:

• B.S. in a Life Sciences discipline and 2+ years of experience within the biologic OR biopharmaceutical industry performing direct hands-on work in a Quality Assurance with a strong familiarity of general GMP documentation and materials management.
• Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks
• Familiarity with electronic systems

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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