Documentation Coordinator - GMP, batch records, SOPs in Franklin Township, NJ at Apex Life Sciences

Date Posted: 3/23/2018

Job Snapshot

Job Description


DOCUMENT COORDINATOR

SUMMARY: Revise and maintain controlled documents such as SOPs, Forms, Master Batch Records, Specifications and Monographs, Protocols. Process Document Change Requests. Maintain training records for all personnel. Scan and file completed batch records and test reports.

ESSENTIAL FUNCTIONS:

  • Revise, route, issue, scan, and file controlled documents including SOPs, forms, master batch records, monographs, test methods, and protocols.
  • Coordinate revision, review, and approval of all GMP documents.
  • Responsible for all document control function, including document login, tracking, processing, distributing and archiving all GMP documents.
  • Maintain and issue batch records to production.
  • Create, issue and maintain controlled forms and logbooks.
  • Scan and file released batch records, component test reports and raw material test reports.
  • Monitor and reconcile all controlled documents.
  • Administer document change control process and maintain document database.
  • Assemble documents required for regulatory submission.
  • Assist in assembling and reviewing documents during regulatory and third party audits.
  • Assist in Quality Investigations.
  • Participate in internal audits and supporting external audits.

QUALIFICATIONS:

  • Bachelor's degree in a Scientific or closely related field preferred
  • Quality professional with three to six months of experience with document control process in pharmaceutical industry.
  • Working knowledge of Microsoft Office programs.
  • Detail-oriented with ability to apply deductive reasoning and understand complicated issues.
  • Must be able to receive and follow written and verbal instructions.
  • Ability to follow safety and security practices including SOPs and GMP
  • Ability to meet deadlines and effectively deal with office stress.
  • Accurately communicate ideas, facts and technical information as needed
  • Maintain confidentiality of certain information.

For immediate consideration, please email your updated resume to TOgele@apexlifesciences.com with 'Documentation Coordinator' in the subject line.