Quality Specialist II at Thermo Fisher Scientific

St Louis, Missouri, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, ManufacturingIndustries

Requirements

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

Responsibilities

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 adapt 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

Skills

Key technologies and capabilities for this role

Deviation InvestigationRoot Cause AnalysisCAPACross-Functional Team LeadershipRegulatory ComplianceQuality AssuranceProcess ImprovementTechnical WritingAuditing

Questions & Answers

Common questions about this position

What education and experience are required for the Quality Specialist II role?

A BS/BA in biology, biochemistry, chemistry, chemical engineering, or other science-related field is required, along with 5+ years of related work experience in manufacturing, process development, or quality assurance in the biotech or pharmaceutical industry.

Is this a remote position or does it require on-site work?

This information is not specified in the job description.

What is the salary or compensation for this position?

This information is not specified in the job description.

What does the company culture emphasize for this role?

The culture empowers development with opportunities for continual growth and learning, supported by significant R&D investment and resources for impactful contributions.

What skills make a strong candidate for the Deviation Investigator position?

Strong candidates have experience with compliance, problem-solving, root cause analysis tools like 5-whys and fishbone, leading cross-functional teams, and mentoring junior employees.

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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