QA Data Coordinator

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.

The QA Data Coordinator will drive the management of batch records and supporting compliance documentation. This individual will play a critical role in the proper and accurate storage and tracking of all related documentation for ease in access during internal and external audits.

Key Responsibilities include but are not limited to:

• Organization and maintenance of executed manufacturing batch records and supporting GMP documentation for batch disposition which includes filing and tracking documentation
• Will conduct training for QA employees on efficient system usage
• Uploads GMP documents into designated software or file locations for review and retrieval
• Responsible for In-process GMP document security, tracking, and for assigning access to approved individuals
• Primary accountability for batch record status within systems and visual board
• Consistent and effective communication necessary to obtain information necessary to maintain tracking tools in real time.

Education & Experience:

• High school diploma/GED
• 2+ years of experience in a pharmaceutical, medical device or biologics environment with some or all of that time in a Quality Assurance or Document Control role
• Experience with Excel, Word and Outlook
• Must be able to use a copier and scanner
• Able to work well under pressure and with a strong attention to detail
• Ability to convey information both verbally and written in a professional, accurate manner
• Must be able to carry and lift boxes containing records up to 40lbs in a repetitive motion if required

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.