Document Control Specialist

apartmentRobert Half placeWoodbridge calendar_month 

We are offering a long-term contract employment opportunity for a Document Control Specialist. This role is based in the pharmaceutical industry and involves the administration of processes and practices supporting documentation compliance. The successful candidate will work closely with Quality Assurance, Quality Control, and Production teams with a key focus on documentation accuracy, quality, and integrity.

Responsibilities:

  • Administer document control processes through electronic and/or paper-based systems.
  • Collaborate with various teams to maintain an up-to-date Document Control System.
  • Perform data entry and management in systems, ensuring the accuracy and integrity of all documents.
  • Store, archive, and retrieve document versions such as certificates of analysis of materials and products, specifications, methods, protocols, and report files.
  • Prepare and distribute controlled documents such as Packaging Batch Records, SOPs, methods, and protocols.
  • Track document approvals and related activities, ensuring online documents are updated and accurate.
  • Work with other departments to clarify and correct documentation to ensure compliance.
  • Maintain the work area and keep up-to-date files.
  • Assist validation and regulatory department for documentation and for their various requirements.
  • Prepare documentation for third-party inspection/audits.
  • Must possess a Bachelor's degree in a relevant field such as Pharmacy, Chemistry, or Biology.
  • Proven experience in document control within the pharmaceutical industry is essential.
  • Proficiency in utilizing Department Standard Operating Procedures (SOPs) is required.
  • Demonstrable knowledge of Quality Assurance (QA) principles and practices.
  • Strong attention to detail with the ability to manage multiple tasks simultaneously.
  • Excellent written and verbal communication skills.
  • Strong organizational skills, with the ability to prioritize and manage time effectively.
  • Proficiency in using Microsoft Office Suite, particularly Excel and Word.
  • Familiarity with document management systems is a plus.
  • Ability to work in a team environment and collaborate with various departments.
  • Must comply with all regulatory standards within the pharmaceutical industry.
  • High level of integrity and professionalism, respecting the confidentiality of work-related information and documents.
  • Ability to adapt to changes in procedures, policies, and job duties.
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