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Document Control Specialist Temp

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Location

Chelsea, MA, United States

Summary

Responsible for performing various administrative tasks in support of the Quality Assurance department and its clients including but not limited to SOP review, supporting the QA Archive, Electronic Document Management System (EDMS), and GxP Training Program.  Participates in independent and team projects as defined by the department manager.

Full Description

Responsible for performing various administrative tasks in support of the Quality Assurance department and its clients including but not limited to SOP review, supporting the QA Archive, Electronic Document Management System (EDMS), and GxP Training Program.  Participates in independent and team projects as defined by the department manager.

*Essential Duties and Responsibilities include the following. Other duties may be assigned:

  • Facilitates the life cycle of master documents (including but not limited to SOPs, Batch Records, Test Methods, Protocols, Reports, Specifications) by functioning as a document workflow coordinator.
  • Reviews, edits, formats master documents according to approved procedures and templates, maintains document properties (metadata), monitors document status and approval notifications and distributions
  • Provides day-to-day support of the electronic document management system (EDMS), and operational controls to maintain the validated state (compliance with 21 CFR Part 11)
  • Collaborates with team to identify opportunities for process improvement in the Document Control program and works cross functionally to implement
  • May assist with end-user training for new users of the EDMS and document control business
  • Participates in Standard Operating Procedures generation 
  • Provides day-to-day operation support for client groups (e.g. scheduling, reporting, records archiving)
  • Assist with metrics generation of monthly periodic reviews for Quality management
  • Supports audits 

Facilitates the archival of GMP documentation and records:

  • Prepares and inspects documents for scanning operations, scans and re-assembles documents
  • Conducts quality assurance tests to ensure images meet quality standards; appends or correct images in response to quality assurance
  • Uploads electronic records into the Electronic Document Management System (EDMS).
  • Files and organizes archival records and develops classification systems to facilitate access to archived records
  • Coordinates the transfer of records with document storage facilities; manages record classifications and storage location in the Record Management System (RMS).
  • Ensures records are maintained according to regulatory requirements including quality SOPs
  • Supports and participates in internal and external audits as requested.

Provides operational support to the GMP Training Program, as needed:

  • Maintain employee training files/database or LMS
  • Processes training files by reviewing data for deficiencies; resolving discrepancies by using standard procedures or returning incomplete training files to the team leader for further review
  • May assist with end-user training of the LMS and user creation
  • Ensures employee training documentation is in accordance with regulatory guidelines

Education and/or Experience:

  • Associates degree
  • Bachelor's degree
  • Minimum of 0-3 years of relevant work experience in the regulated Biotechnology or Pharmaceutical industries or relevant comparable background highly
  • Experience with Electronic Document Management and Learning Management Systems preferred (EDMS: Qumas/Biovia) (LMS: SumTotal)
  • Familiar with applicable regulatory requirements (e.g. 21 CFR Parts 11, 210, 211, 820).

Supervisory Responsibilities: None

Qualifications:

  • Excellent oral and written communication skills.
  • Exhibits a basic understanding of general quality assurance concepts and practices.
  • Demonstrates ability to understand established procedures and effectively communicate such procedures to others.
  • Demonstrates attention to detail.
  • Possess the ability to comprehend assignments and manage client expectations.
  • Strong organizational skills required.
  • Works to solve problems of moderate complexity.
  • Ability to manage both day-to-day operations as well as project work in a fast paced environment.

Computer Skills:

  • Must be proficient in MS Office Suite. Certificates, Licenses, Registrations: None Required

Physical Demands:

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

  • Requires physical activity such as standing for long periods of time, walking, bending, and working with hands.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

  • No specific work demands.

*To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.