Engineer III, QA

at  Thermo Fisher Scientific

JOB DESCRIPTION

Want to make a difference? Become a part of a successful and respected team within Thermo Fisher! The Product Release Specialist (Engineer
III, QA) will lead quality assurance programs, procedures and controls, ensuring that finished devices are labeled, 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 for leading the effort to ensure that sophisticated device history records (DHR) are maintained in an organized manner and able to be assembled quickly for audit purposes.

In the Specialty Diagnostic Group, we help Thermo Fisher achieve its Mission by enabling human healthcare. Across our six divisions, we offer a range of diagnostic test kits, reagents, culture media, instruments and associated products to serve customers in healthcare, clinical, pharmaceutical, industrial and food safety laboratories. At the West Hills site, we are committed to improving the quality of life of transplant patients and their families by developing and producing innovative, high quality HLA products for the clinical and research segments of the transplant community!

• Perform product inspections as the need arises while also implementing conformance to specifications and reviewing production, packaging/labeling and laboratory documents for final product release
• Systematically release finished and semi-finished product based on conformance to established standards
• Review label submissions as required and produce labels to ensure conformance to specifications
• Assemble, manage, 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
• Show initiative and ownership with leading document preparation/presentation for regulatory agency visits and Corporate/internal audits.
• Provide real-time support to Product Packaging to prevent backorders, 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, ensure quality and compliance and safety in all their actions.
• Complete all required trainings appropriately. Attend GMP training vital for the role. Implement 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.

MINIMUM QUALIFICATIONS

• Bachelor’s degree in a biological or related science from an accredited college or university.
• 5 years related QA or QC experience in a GMP regulated environment.
• Previous experience reviewing and releasing batch records for Medical devices is also preferred.
• Excellent analytical, prioritization, multi-tasking and communication is required.
• Strong leadership skills and capability to work independently without supervision are required.
• This candidate is required to work optimally on cross functional teams and command outstanding communication skills, both written and verbal including the ability to present to a broad audience as needed.

WORKING CONDITIONS/PHYSICAL REQUIREMENTS:

Desk work, including long periods of sitting/standing in front of PC. Non-remote.
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.

Please refer the Job description for details