QA Document Control Specialist

Thermo Fisher Scientific Lexington, MA

About the Job

QA Document Control Specialist

Requisition ID:

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

Location/Division Specific Information

Lexington, MA

This position will be Monday-Friday 8am-5pm

How will you make an impact?

The QA Document Control Specialist will act as a direct liaison between departments and the site’s quality unit to ensure adherence to document creation, modification, control, storage and retention requirements. The QA Document Control Specialist is an associate with an extensive level of expertise and experience in document control and records management, has a general knowledge of biopharmaceutical manufacturing and a good understanding of cGMP and safety standards. The QA Document Control Specialist with subject matter expertise in document control will work with departments to plan, develop, author, edit, format, illustrate, update and create new standard operating procedures and other related documentation such as master batch records, logbooks, job aids and technical reports in support of cGMP. Primary responsibilities include managing documentation workflows to meet departmental needs; onsite and offsite archival and tracking of records; maintenance of the site archive and retrieval of records to support audits, inspections and investigations; issuing GMP documentation to respective departments.This role will interface closely with other cross-functional groups such as Operations, Facilities, Engineering, QC, Business Management and Quality.

What will you do?

  • QA Document Control Specialist will manage document workflows in Thermo Fisher Scientific’s electronic document management system ensuring documents go through controlled document life cycle in accordance established procedures.
  • Ensure documents meet formatting and template requirements, adhere to required review and approval requirements and project time lines.
  • Manage GMP documentation tracking, reconciliation and archiving
  • Manage high density file room inventory, filing, and scanning. Manage offsite document archival with approved vendors
  • Perform GMP document and label issuance
  • Perform documentation coordinator activities in eDMS and work with departments on documentation needs.
  • Provide site training on document workflow modules
  • Author or revise standard operating procedures related to document control, as needed
  • Provide documentation support during client audits and regulatory inspections.
  • Assists with the improvement of quality compliance by recognizing continuing issues and bringing them to management’s attention
  • Subject Matter Expert (SME) in assigned scope of controlled document lifecycle and records management process
  • Communicates internally, inter-organizationally and with cross site document management contacts frequently
  • Maintains quality system program requirements, e.g., record retention and destruction, legal hold
  • Support compilation of department metrics and report out to management. Coordinate collection and compilation of slides for management review meetings such as QMR and Quality Council
  • Generate and report out meeting minutes for routine QS meetings such as deviation review board, change control review board and CAPA review board

How will you get here?

Bachelor’s Degree in Life Sciences discipline (or equivalent years of experience) and 4+ years of experience in a cGMP environment, with strong knowledge of document management activities. Experience in writing GMP standard operating procedures which adhere to regulatory requirements

  • Proficient in an eDMS system and document formatting
  • Demonstrated ability in performing document coordination and archival activities
  • Demonstrated ability in managing tracking databases

Knowledge, Skills, Abilities

  • Skilled in use of Microsoft Outlook, Powerpoint, Word, Excel and GMP system programs and spreadsheets is mandatory, as is a capacity to follow written procedures, and the ability to read, write, speak, understand and to be understood in English.
  • This position requires the ability to work in a fast-paced team environment to meet goals and timelines and as such requires appropriate behavioral characteristics to be effective and successful. Individual must be self-motivated, have excellent quality and organization skills and be detail oriented.
  • Strong interpersonal and communication skills and the ability to work effectively across all levels.

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Apply today!

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.