Quality Specialist II
Quality Specialist II
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1 Vacancy
Job Description
Work Schedule
Standard (MonFri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards OfficeJob Description
When youre part of the team at Thermo Fisher Scientific youll do important work. And youll 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 worldclass Manufacturing team in St. Louis. As a Deviation Investigator you will play a crucial role in ensuring the successful of our operations by investigating and analyzing deviations or nonconformances that arise in various aspects of our companys 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 crossfunctional teams through complex investigations and complete milestones onschedule.
- 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 crossfunctional 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 bestinclass 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 sciencerelated 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 problemsolving simple and complex root cause analysis tools 5whys fishbone fault tree is/is not etc. critical thinking project management and quality systems.
- 5 years of experience in direct utilization of problemsolving 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 fastpaced environment and prioritize tasks.
- Ability to facilitate meetings for desired outcomes.
- Proven experience with root cause analysis and CAPA processes.
- Excellent analytical and problemsolving 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 remuneration annual incentive plan bonus healthcare and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative forwardthinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!
*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes such as not being able to get into the career website following up on an application or other nondisability related technical issues will not receive a response.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
