Quality Specialist II

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. And you’ll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Discover Impactful Work:

Thermo Fisher Scientific Inc. is seeking a motivated and ambitious Deviation Investigator to join our world-class Manufacturing team in St. Louis. As a Deviation Investigator, you will play a crucial role in ensuring the successful execution of our operations by investigating and analyzing deviations or non-conformances that arise in various aspects of our company's operations, including Manufacturing, Quality Control, and Facilities.

A day in the Life:

• Manage Major deviation investigations, including assembling investigation teams, leading root cause analysis, development of CAPAs, and compliant documentation of all findings.
• Drive improvements to the investigation process.
• Present investigations to regulatory inspectors, internal auditors, and management.
• Clearly communicate investigation progress to impacted areas and leadership.
• Coordinate and effectively lead cross-functional teams through complex investigations, and complete milestones on-schedule.
• Present complex topics to large and small groups at various levels and quickly understand and clearly communicate complex issues.
• Document findings in a comprehensive and objective manner, ensuring accurate recording of all relevant information.
• Ensure timely completion of investigations.
• Collaborate with cross-functional teams, including manufacturing, quality assurance, process engineering, and regulatory affairs, to gather information, evaluate causal factors, and implement corrective and preventive actions (CAPAs).
• Regularly adapts standard Root Cause Analysis methods and techniques to unique investigations, using expertise to select the best-in-class approach.
• Provide timely written documentation of investigations and communicate recommendations based on investigation outcomes.
• Participate in client communications and responses, working closely with program team leads, quality, and management.
• Continuously improve investigation processes and tools to enhance efficiency and effectiveness.
• Mentor junior employees on performing investigations, root cause analysis, and identifying effective CAPAs.

Keys to Success:

Education

• BS/BA in biology, biochemistry, chemistry, chemical engineering, or other science-related field.

Experience

• 5+ years related work experience (manufacturing, process development, or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility
• Experience with compliance, problem-solving, simple and complex root cause analysis tools (5-whys, fishbone, fault tree, is/is not, etc.) critical thinking, project management, and quality systems.
• 5+ years of experience in direct utilization of problem-solving tools (Root Cause Analysis and/or LEAN/six sigma experience) with demonstrated success.
• 3+ years of experience working in biologics preferred.
• Experience using a Quality Management System such as Veeva or Trackwise.
• Strong understanding of regulatory requirements (e.g., FDA, EMA, ISO) and Good Manufacturing Practices (GMP).

Knowledge, Skills, Abilities

• Strong written and verbal communication skills.
• Ability to evaluate data and make recommendations based on trends and trend analysis.
• Ability to work effectively in a fast-paced environment and prioritize tasks.
• Ability to facilitate meetings for desired outcomes.
• Proven experience with root cause analysis and CAPA processes.
• Excellent analytical and problem-solving skills.
• Ability to work independently and manage multiple investigations simultaneously.

Physical Requirements / Work Environment

• Able to adhere to clean room gowning requirements, including wearing Tyvek, Nitrile, and/or Latex gloves
• Be willing to wear a full gowning suit which includes: bodysuit, gloves, hair & beard nets, face covers, and safety glasses. (These items are prohibited: makeup, jewelry, nail polish, cologne / perfume, scented lotions or hair care products, etc.)
• Experience in cGMP environment preferred

Benefits

We offer competitive remune