Thermo Fisher Scientific Supervisor, QA Documentation in Somerville, Massachusetts
At Viral Vector Services (VVS) a division of Thermo Fisher Scientific we deliver, from process development through commercial supply, we offer the expertise and resources necessary to help clients deliver innovative gene therapies. Placed in the forefront of our leading and cutting edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases
How will you make an impact?
The Supervisor, QA Documentation will oversee a team of quality associates and specialists responsible for daily support activities related to document control and archiving.
What will you do?
Maintain the document control system and assure compliance with applicable procedures.
Schedule and assign the review and completion of workflows for controlled documents.
Ensure that all documentation within the group is completed to the highest quality standards.
Manage the archive system for all document at the site.
Coordinate the offsite archival of documentation.
Ensure archive and retention policy is followed and documents are maintained in an organized and secure manner
Actively engages in continuous improvement for areas of responsibility, collaborating with other departments to identify and implement process efficiencies
Lead and assist problem-solving and root-cause analysis sessions.
Evaluate and work with other departments to reduce preventable deviations through procedure creation, revision, or processing mapping.
Support client audits and regulatory audits.
Oversee a team of Quality Associates and Specialists responsible for daily support activities related to documentation control.
How will you get here?
At least 3 years of experience in a Quality Assurance group in a biopharmaceutical or pharmaceutical cGMP regulated environment
Preferred experience working in a supervision and/or leadership role
Previous supervision and/or leadership experience
Must have a complete knowledge of current Good Manufacturing Practices, United States Pharmacopeia, current Code of Federal Regulations (21CFR parts 11, 210, and 211) and other DFA, European and global guidance's.
Knowledge, Skills, Abilities
Excellent written and oral communication skills.
Demonstrated ability to present ideas persuasively and negotiate effectively
Strong analytical and problem-solving skills; great attention to detail and excellent decision-making process.
Demonstrated ability to manage cross-functional teams and collaborate across the business.
Must have working knowledge of Microsoft Office, ERP Systems and be able to quickly learn new software
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
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