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 Product Release Specialist will maintain quality assurance programs, procedures and controls, ensuring that finished devices are inspected and/or reviewed to ensure they meet medical device requirements and are of the highest quality standards prior to release for sale. This role will also be responsible to ensure that the device history records (DHR) are maintained in an organized manner and able to be assembled quickly for audit purposes.
- Inspect finished goods as required to ensure conformance to specifications
- Review and approve label submissions as required to ensure conformance to specifications
- Review of production, packaging/labeling and laboratory documents for final product release
- Assemble device history records
- Systematically release finished and semi-finished product based on conformance to established standards
- Scan and archive DHRs and ensure legibility and accuracy of electronic storage
- Participate in Non-Conformance and CAPA investigations and help to develop solutions to system and procedural problems
- Maintain ownership of SOPs and train colleagues on SOPs as needed
- Generate, identify, and suggest quality/process improvements
- Writing as well as assist others in writing new or updated operating procedures and/or work instructions
- Assist in document preparation/presentation for regulatory agency visits and Corporate or internal audits.
- Provide real-time support to Product Packaging and Labeling groups to prevent backorder, non-conforming materials release and adherence to the production schedule.
- Under limited supervision and in accordance with all applicable federal, state and local laws/regulations, the Companies’ policies, procedures and guidelines, the Product Release Specialist will ensure quality and compliance and safety in all their actions.
- Complete all required trainings in a timely manner and attend GMP training as appropriate for the role.
- Adhere to strict compliance with procedures applicable to the role. This individual will exercise the highest level of integrity in the tasks performed.
- In a timely and prompt manner, identifies, reports, and seeks correction for deviations noted in the workplace. Practice all behaviors in a safe and environmentally responsible manner.
- Bachelor’s degree Life Sciences, Biology, or related field
- Three (3) years of related QA or QC experience
- Excellent analytical, prioritization, and multi-tasking skills
- Strong attention to detail and the ability to follow comprehensive instructions
- Ability to communicate clearly both in writing and verbally, using proper English grammar
- Ability to work independently without supervision and take initiative where needed
- Ability to exercise independent discretion and judgment in execution of his/her duties
- Strong technical aptitude and proficient in Microsoft Office including Word and Excel
- Capacity to learn new applications and procedures quickly
- Innately plans and organizes oneself in an efficient and consistent manner to prioritize multiple tasks daily
- Ability to work effectively on cross functional teams
- Prior experience reviewing and releasing batch records
- Experience in a GMP regulated environment
- Ability to prepare and present written and verbal reports
- SAP transactional experience
This position has not been 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.