Thermo Fisher Scientific QA Document Control Specialist in Lexington, Massachusetts
QA Document Control Specialist
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
How will you make an impact?
The QA Document Control Specialist will act as a direct liaison between deparments and the site's quality unit to ensure adherence to document creation, modification, control, storage and retention requirements. 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.
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 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! http://jobs.thermofisher.com
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.
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