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 Engineer II, QA will work closely with Unity Lab Services to ensure strict compliance with GMP guidelines, specifically to ensure that all equipment is maintained in GMP compliance and that calibration and maintenance activities are executed on schedule.
- Conduct necessary training on Blue Mountain for all staff as needed for use of the system
- Assist in the maintenance and review of calibration standards and vendor calibration documentation
- Test software applications to compare to functional requirements, specifications, and documentation in GMP business
- Validate Excel spreadsheet, spreadsheet functions and automated calculations
- Assist manufacturing process owners in the identification, implementation and monitoring of applicable process controls using quality tools/metrics to ensure accurate assessment of consistent quality outputs
- Review and approve IQ/OQ/PQ documents, review change requests for major instrument life events and/or relocation prior to re-qualification
- Review and manage process change requests, assist with CAPA plans and interface with R&D and Manufacturing departments regarding change requests, process validation and DMR amendments
- Help analyze failure, identify corrective and preventive action to respond to customer complaints
- Applies statistical methods to develop and evaluate metrics for improvement opportunities
- Assist executing validations if needed and provide supporting documentation Perform other related duties as assigned or required
- To support manufacturing operations by ensuring compliance to calibration and maintenance of all equipment as required by site quality systems through Blue Mountain.
- Review of change requests, qualification protocols, reports and DMR documents
Contacts and Relations:
- Regular contact and interaction with all levels of the organization
- Frequent contact will take place with service providers
- Daily interaction will occur with technical product owners and manufacturing personnel
- All QA personnel are expected to maintain the confidentiality of sensitive laboratory information including testing data
- Maintain a cooperative and professional relationship with other laboratory staff and departments, as well as a positive relationship between OLI and third-parties must be maintained at all times
- Bachelor’s degree in Life Sciences or related studies
- Two (2) years of quality experience in an IVD industry or in a cGMP, ISO regulated Medical Device or Pharmaceutical manufacturing environment
- Good knowledge of cGMP and ISO 13485 quality system requirements
- Familiar with statistical techniques, data analysis and continuous improvement disciplines
- Exercise independent discretion and judgment in execution of duties
- Plan and organize oneself in a consistent manner
- Be a self-starter with the ability to positively motivate others in a cooperative fashion
- Establish and maintain effective working relationships with other staff members
- Effectively communicate both orally and in writing to staff, management, customers and regulatory personnel
- Maintain confidentiality of sensitive laboratory information; perform computer operations for data entry
- Validation and Project management experience
This position is currently not 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.