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Document Control Coordinator

Harmans, MD

Posted: 09/29/2020 Industry: Manufacturing Technician Job Number: JN -092020-12031

Job Description

Document Control Coordinator III

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
Environment: This client manufactures thousands of pharmaceutical, biologic, consumer health and beauty products utilizing superior and innovative drug delivery technologies to improve their value to patients and consumers. Our customer believes in a Patient First culture putting patients at the center of their work to ensure the safety, reliable supply and optimal performance of our products.

Job Scope:

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.

Job Duties:
  • 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.

EOE/ADA


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