Document Control Lead (cGMP – Pharmaceutical)

Document Control Lead cGMP Pharmaceutical

 

AM Technical Solutions- Who Are We:

AM Technical Solutions (AM), founded in 1994, is a proven and licensed architecture, engineering, and construction firm bringing innovative solutions to the Biopharma industry to help in the fight to save lives.  Our knowledge and expertise in high-tech spaces combined with our culture-first mentality allows our team to deliver the entire scope of work for high-tech construction projects on schedule, on budget, and at the level of quality required by customers.  AM Life Science being an integrated part of AM Technical Solutions brings new energy and ideas to an ever-changing industry. Our team is comprised of motivated, intelligent, capable and qualified individuals who design, execute and manage projects and programs that implement risk-based approaches utilizing scientific data and justifications to align with the regulatory and industry standards. AM Life Science takes pride in our accuracy, efficiency, and integrity, which translates into cost and time savings for our Clients.

 

Job Title:  Document Control Lead (cGMP – Pharmaceutical)

Current Locations:

Boston, MA area

 

Position Description

AM Technical Solutions is looking for a Document Control Lead to assist with a BioPharma client of ours in the Boston, MA area. This individual would be expected to set up a document management system suitable for the multi-million dollar project and would be a key person responsible for managing the document flow for the project from A/E, CM, Vendors, C&Q, etc.

 

Direct Involvement Opportunities:

  • Must have document management knowledge including ability to organize documents for distribution, traceability, retrieval, and archiving; all consistent with contract requirements and workflow procedures.
  • Project Correspondence.
  • Change Management.
  • RFIs and Submittals, saving and tracking.
  • Meeting Minutes, document control and distribution.
  • Safety Information and Reports.
  • Earned Value documentation and graphics tracking.
  • Contractor Schedules and EV tracking and reporting.
  • Assembling multiple presentations.
  • Ensuring that all required signatures are included on project documentation.
  • Maintaining the project’s library of technical documents (blueprints, As-builds, Photographic archiving).
  • Maintaining archived engineering, architectural, and construction documents, including design drawings, vendor submittals, shop drawings, design review records, special studies, and other documents as required.

 

Qualifications, Skills, And Experience:

  • Bachelor’s degree is desired but not required and replaceable by experience.
  • Minimum of 4+ years of experience as a document control specialist is required.
  • Requires excellent organizational, interpersonal, and communications skills.
  • Must exhibit professional behavior and appearance and be aware of the importance of teamwork within the assigned department.

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