Document Control Coordinator - Pharmaceutical/Biotech

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 Gaithersburg, Rockville, 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 Document Control Coordinator oversees the revision, issuance and tracking of controlled documents used to support the Phase I/II/III and commercial GMP manufacture of bulk and sterile fill biologics. Mature professional capable of working independently and in a team setting. Continually evaluate opportunities for improvement to increase efficiency while ensuring compliance to applicable regulatory requirements and standards. Requires the ability to produce results in a fast-paced environment to meet client deadlines and to effectively prioritize based on criticality.

Key Responsibilities include but are not limited to:

• Decisions or recommendations consistently result in favorable project results and client satisfaction.
• Will work directly with Clients, the QA department and other Paragon departments to revise, issue and track controlled documents to meet timelines. Provide status updates and reminders when necessary.
• Ensures basic grammatical accuracy and completeness when revising documents.
• Filing, tracking and archival of GMP documentation.
• Conducts internal audits of Paragon systems and documents where needed to ensure compliance to applicable Paragon Policies and SOPs.
• Provides reports to Upper Management and Project Management regarding document status
• Maintains databases used for tracking various GMP documentation.
• Support regulatory (FDA, EMA) and client audits/inspections of Paragon.
• Works under general supervision to meet project goals.
• Compile and provide applicable metrics for periodic Management review.
• Support Process Development (PD) as needed.
• Will work closely with various departments at Paragon to resolve quality issues and offer assistance as needed.
• Assist in review of cGMP controlled documents as necessary, including decision making of where new controlled documents fit within the QMS.
• Issuance of Batch Production Records.
• Participates in resolving deviations associated with the Document Management System
• Handles non-routine situations for review and approval by senior staff
• Participates in the development, implementation and monitoring of training programs

Education & Experience:

• High School Diploma and 3-10 years experience with Good Manufacturing Practices (GMPs) in the pharmaceutical, biologic or medical device industries in a Document Control position, including the revision, issuance and tracking of batch records, Standard Operating Procedures (SOP), Specifications, etc.
• Microsoft Word and Microsoft Access experience
• Exposure to 21 CFR Parts 210 & 211, biotechnology, Process Development (PD) and electronic validated computer systems a plus.

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.

#LI-EW1