Document Control Coordinator
SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
- Title: Document Control Coordinator III
- Location: Gaithersburg Site - Montgomery, County
- Industry: Pharmaceutical
- Hours: Mon-Fri 8AM - 5PM
- Salary: $34hr (Paid Weekly - Benefits Available)
- Employment Type: 6 month Contract
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.
- Will work directly with Clients, the QA department and other departments to revise, issue and track controlled documents to meet timelines. Provide status updates and reminders when necessary.
- Filing, tracking and archival of GMP documentation.
- 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
- Will work closely with various departments at Paragon to resolve quality issues and offer assistance as needed.
- Processes, distributes, and maintains controlled documentation (i.e., SOPs, SMPs, material specification, logbooks, etc.) using a document control system.
- Issuance of Batch Production Records.
Experience & Education:
- High School Diploma and 6 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.
- Experience with Electronic Database Management System strongly preferred.