Document Specialist I

    • Job Tracking ID: 85430-269512
    • Job Location: Cambridge, MA
    • Job Level: Any
    • Level of Education: Any
    • Job Type: Full-Time/Regular
    • Date Updated: 07/19/2018
    • Years of Experience: Not Applicable
    • Starting Date: ASAP
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Job Description

JOB SUMMARY/OBJECTIVE:

The document specialist 1 is an associate with a minimal level of expertise and experience with general biopharmaceutical manufacturing equipment, principles and processes and has a good understanding of current GMP and safety standards. The DS1 collaborates with subject matter experts and technical specialists to plan, develop, author, edit, format, illustrate, update, and create new standard operating procedures and other related documentation such as PBRs, logbooks, job aids and technical reports in support of the cGMP compliant Manufacturing facility. Responsibilities include maintaining established documentation design and quality standards, using performance tools (Human Performance) and managing documentation workflows to meet departmental needs. Additional responsibilities may include administrative duties to manage and process controlled documents for the manufacturing facility.

ESSENTIAL JOB FUNCTIONS:

  • Collaborates with area SMEs or technical specialist to create or revise existing procedures or documents for use in the manufacturing facility.
  • Obtains and verifies accuracy of technical details, manages documentation workflows and schedules and proofreads drafts for adherence to established document design and quality standards.
  • Performs administrative duties related to managing controlled document life cycles from issuance to Manufacturing through archival with Quality Assurance.
  • Responsibilities may include maintaining the GMP manual of Standard Operating Procedures and management of logbooks for the manufacturing operations.
  • Provides training to junior associates on established writing standards for documentation design and quality.
  • Training provided may also include company policies, programs and procedures commensurate with their experience as a qualified trainer.
  • Participates in initiatives to support, innovation and continuous improvement activities and improved compliance with quality procedures, policies and regulations.

Experience and Skills

POSITION REQUIREMENTS:

  • The DS1 must be skilled in the use of a personal computer and related software applications.
  • The DS1 must have strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.
  • The DS1 must be skilled in meetings and interviews to eliciting technical details from subject matter experts.
  • The DS1 must be able to provide effective written or verbal communication to peers, senior associates, and area management within their operational group
  • The DS1 must be able to develop logical structure for technical documents, content and illustrations
  • The DS1 must be detail oriented while proofreading documents.
  • The DS1 must be able to recognize, understand and respond to situations requiring further evaluation and report these events (process, safety, personnel, etc..) to senior specialists or area management.
  • The DS1 must be able to understand operational documents for GMP compliance, accuracy and completeness.

EDUCATION AND QUALIFICATIONS:

  • Bachelor’s Degree in Life Sciences
  • 1-3 years’ industry related experience with a Bachelor’s Degree
  • 2-4 years’ industry related experience with an Associate’s Degree/Certificate Program
  • 3-5 years’ industry related experience with a high school diploma
  • Strong interpersonal and communications skills; written and oral.
  • Solid understanding of applicable regulatory requirements.

PHYSICAL DEMANDS/FACTORS:

While performing the duties of this job, the employee:

  • Ability to function in a dynamic environment and balance multiple priorities simultaneously
  • Ability to learn new software and tools quickly.
  • Ability to make decisions and work with minimal to moderate supervision.
  • Ability to aseptically gown and/or sterile gown as needed.
  • While performing the duties of this job, the employee is required to write, read/review written documentation for extended periods of time. Specific vision requirements for this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
  • Is regularly required to talk and hear. The employee frequently is required to sit and stand for extended periods. The employee is occasionally required to lift, stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel, or crouch.

Note: This job description is not all-inclusive. Additional duties may be performed, as assigned. It acts as a guideline and is subject to change over time.