Title: Document Control Specialist

Responsibilities

  • Issue and print Batch Manufacturing Records to production to align with the manufacturing schedule at various sites.
  • Maintain the appropriate files and logs.
  • Review documentation for completeness.
  • Process, track and retrieve SOPs, protocols, reports, policies, etc. using an electronic document management system. This includes obtaining electronic review and approval of documentation.
  • Prepare SOP’s being made effective. Supersede or obsolete previous revisions. Update SOP Book Sets accordingly.
  • Control the issuance/distribution of SOP attachments and other executable documentation. Track and document accordingly.
  • Prepare and track various documents for training.
  • Compile documentation related to manufacturing changes for Annual Product Reviews (APRs). Also, scan, bookmark and archive APRs.
  • Scan documentation and prepare for archival. Log and prepare documents for destruction.
  • Utilize the retention database to enter and retrieve records. Box up and relocate archived boxes of documents to/from various site locations.
  • Prepare logbooks according to SOP’s. Issue to applicable departments and maintain tracking log. Archive completed logbooks.
  • Maintain physical files, paper book sets and master files. Also, process, distribute, file, track, retrieve, copy and archive a variety of documents manually when needed.
  • Distribute documents to various departments within the company and document accordingly.
  • Provide administrative and clerical support.
  • Perform other duties as assigned.

Qualifications

College degree preferred with some related experience or High School diploma coupled with 2+ years related experience. CGMP documentation experience preferred. To perform this job successfully, an individual must possess excellent typing ability and computer skills as well as oral and written skills. Individual must be proficient in Microsoft Office applications such as Word and Excel. Electronic document management experience is preferred. Strong organizational skills are necessary to manage multitask activities. Detail oriented, especially with regards to proofreading, required to ensure accuracy and completeness of documentation.

Knowledge and Skills

Language Skills

Ability to read/write and comprehend instructions, correspondence and memos. Ability to effectively present information in a one-on-one or group situation. Read, write and understand English.

Mathematical Skills

Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Reasoning Ability: Ability to apply principles of logical thinking to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problem solving involving several concrete variables in a wide range of practical situations.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit, talk and hear. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.

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