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.
The Quality Specialist II is responsible for managing and implementing the processes associated with the creation of new, and revision of existing, labeling content documents throughout the complete product lifecycle. This position works with the appropriate groups and subject matter experts to ensure proper product labeling content is developed. The position will have responsibility for the accuracy of labeling documents and associated change control.
Additionally, the position will ensure the representation of labeling content is accurate on labeling artwork, and that artwork is compliant with regulatory requirements. The position also ensures compliance to internal labeling policies and procedures, and ensures product labeling content is consistent with health authority regulations. The position will be involved with responding to internal and external labeling audits and activities related to the development and maintenance of applicable labeling procedures, guidelines, and document templates. Additionally, this position is responsible for the development and delivery of training to pertinent functional units regarding labeling processes and supporting systems-based tools.
- Maintain a label management system compliant with regulatory, quality, and Transplant Diagnostics (TDX) business requirements
- Analyze and recommend guidance on approved procedures, standardization and requirements associated with the label management system
- Simultaneously and independently lead change control of assigned label/labeling documents in a timely manner
- Implement strategic initiatives to improve the labeling change management system
- Investigate deviations against the labeling management system and develop effective corrective action plans
- Execute the label/labeling change process so that only approved and validated changes are incorporated into effective product and process documentation
- Ensure accuracy by reviewing labeling documents for completeness, proper authorization and impact to other quality systems
- Collaborate with cross-functional departments to ensure timely implementation of label change requests and labeling change requests
- Prepare and submit printed labeling documents for packaging/shipping as needed.
- Ensure regulatory compliance of all labels/labeling documents for foreign countries
- Provide assistance with editing, formatting and final drafting of labeling documents as requested and approved by supervisor
- Support audits (internal, external) in order to verify that regulatory and quality requirements have been met
- Act as enLabel System Administrator, and back up Master Control System Administrator
- Manage all documentation and records issuance and archival processes to support clinical and commercial manufacturing
- Analyze and recommend guidance on approved procedures, standardization and requirements associated with the document management system
- Work independently, or with peers, to actively improve processes and procedures, as well as develop and implement solutions
- Regularly interact and communicate with all TDX staff, maintaining cooperative and professional relationships
- Keep confidential all laboratory data and business information
- Bachelor’s degree in Life Sciences or related field from an accredited higher learning institution
- 3 years of experience in a quality document management, quality engineering, validation, and quality assurance or quality systems
- Demonstrated working knowledge of quality systems in areas such as document management, document change control audits, batch record and label issuance
- Working knowledge of quality systems and regulatory requirements (21 CRF Part 820; ISO 13485)
- Excellent organizational skills and ability to review processes or procedures
- Ability to communicate and work independently with scientific/technical personnel
- Experience in pharmaceutical or bio-pharmaceutical field
- Ability to create presentations, work with spreadsheets, prepare reports and write procedures utilizing MS Word, Excel, and PowerPoint software applications
Working Conditions/Physical Requirements:
- Operate a computer terminal on a daily basis and requires long periods of sitting
- Occasionally lift equipment of up to 35 pounds
- Direct labeling or technical writing experience
This position is not currently budgeted for relocation.
At Thermo Fisher Scientific, each one of our 50,000 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.