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 a real-world impact, and you’ll be supported in achieving your career goals.

Location/Division Specific Information

Pharmaceutical Services Group/Biologics – St. Louis, MO

How will you make an impact?

The Quality Specialist is responsible for being the primary liaison between the operations and quality teams. This role is critical to ensure the compliance of the operational processes in accordance with cGMP guidelines.

What will you do?

• Lead cross-functional harmonization of Quality Specialist team within the Operational Focus Factories.
• Partner with operations, site quality, engineering, and maintenance to develop applicable SOP’s, Batch Records, and Training Documents.
• Conduct periodic reconciliation of logbooks and ensure standardization of entries.
• Partner with quality and operations leadership to ensure good quality and cGMP practices and their implementation in new product launch.
• Generate and maintain quality risk assessments, including Failure Mode and Effects Analysis (FMEA).
• Provide support for and manage preparation of documentation for regulatory filings.
• Track all activities in appropriate quality management systems (i.e. deviations, CAPAs, Change Controls, etc.) and drive to closure.
• Act as liaison between quality and operations.
• Oversee compliance of focus factory and execute compliance walk-thus providing respective feedback to the operational teams for improvement and sustainability.
• Coordinate and lead QRAs within focus factory.
• Design, generate, track, and communicate quality metrics within the focus factory.
• Track MBR closures to meet disposition deadlines.
• Coach Operations on cGMP, Good Documenting Practices (GDP), and deviation initiation.
• Facilitate Quality improvement projects.
• Support Operations with Planned Deviations.

How will you get here?

Education

Associate's or Bachelor’s degree in a scientific or related field, preferable

Experience

Three (3) to five (5) years of progressive experience within Biological or Pharmaceutical environment, preferred.

In addition to GMP’s documentation experience, such as exposure to manufacturing or quality environment preferred.

Equivalency: Equivalent combinations of education, training, and relevant work experience may be considered.

Knowledge, Skills, Abilities

• Understanding of production processes and the biopharma production environment.
• Knowledge in GMP’s practices and FDA regulations
• Understanding of cGMP quality systems (e.g. change control, deviations, investigations, batch records, quality metrics, audits, work orders, regulatory compliance, CAPA’s , etc. ) driving GDP within all documentation and records.
• Strong decision making skills.
• The ability to handle multiple ongoing activities and ability to prioritize tasks
• Outstanding attention to detail and organizational skills. Self-starter, mature, independent and dependable
• Demonstrate ability to achieve goals and evaluate/resolve complex technical problems. Ability to motivate, energize and collaborate with others. Lead by example.
• Ability to work in a fast paced environment under pressure; able to multi-task and results-oriented.
• Highly effective verbal and technical writing/communication skills.
• Strong computer/ software skills (i.e. Outlook, Excel, Word, PowerPoint, SAP, Track Wise, Success Factor, Compliance Wire, etc)

At Thermo Fisher Scientific, each one of our 75,000 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.