Thermo Fisher Scientific
Quality Specialist I
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Quality Specialist I
Quality Specialist I – Manufacturing Operations Excellence
Thermo Fisher Scientific
About the Role
As part of the Thermo Fisher Scientific team, you’ll play a vital role in shaping a healthier, cleaner, and safer world. Our end goal is to empower global teams to achieve both personal career aspirations and organisational success while tackling some of the world’s most pressing challenges—从食品安全保障 to environmental sustainability and medical advancements like curing cancer.
This Quality Specialist I position will ensure quality compliance across manufacturing operations, driving excellence in product delivery and operational integrity.
Work Schedule
- Standard Shift: 7.5 hours
Location
- Office-based environment
Description
Join our high-performing team, where you’ll uphold strict quality oversight by:
- Reviewing detailed documentation (e.g., GMP, batch records, quality records)
- Monitoring process compliance and supporting continuous improvement
- Collaborating cross-functionally to investigate quality events
- Contributing to a culture of precision, reliability, and innovation, ensuring life-changing products reach global customers
Responsibilities
Your role will include, but is not limited to:
- Quality Control:
- Review, approve, and verify GMP records, batch documentation, and quality systems compliance
- Ensure adherence to ISO-specific regulations and other regulatory standards
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Process & Risk Management:
- Execute Corrective Action/Preventive Action (CAPA) and change control methodologies
- Apply root cause analysis (RCA) to resolve quality incidents
- Foster a focused culture of quality, driving proactive improvements
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Collaboration & Communication:
- Act as a liaison between regulatory teams, engineering, and manufacturing
- Maintain strong documentation and technical writing for reports and regulatory needs
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Technical & Standards Expertise:
- Operate effectively within quality management systems (QMS) (e.g., ISO, CAPA tools)
- Apply experience in manufacturing environments, environmental monitoring, and contamination control
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Tactical Compliance & Adaptability:
- Work within controlled manufacturing environments, including gowning requirements
- Handle physical demands such as standing, walking, and lifting (~25 lbs on occasion)
Requirements
Educational & Experience:
- Bachelor’s degree required; preferably in Chemistry, Biology, Engineering, Life Sciences, or a related scientific field
- Minimum 2 years of experience, optimally within regulated manufacturing environments or similar compliance-driven roles
Technical & Soft Skills:
- Certifications: Hold or pursue relevant credentials (ISO auditor certifications, Six Sigma preferred)
- Documentary Skills: Proficient in technical writing, GMP documentation, and quality record reviews
- Systems Proficiency: Familiarity with quality software (e.g., SAP, LabWare, ELN) and Microsoft Office applications
- analytics & problem-solving with meticulous attention to detail
- Skilled communicator: Excel in both verbal and written correspondence to articulate findings and solutions
- collaborative mindset: Adaptable in cross-functional teams with strong independent work ethos
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Regulatory & Technical Knowledge:
- Comprehensive understanding of quality management systems (QMS), including ** CAPA processes**
- Breadth of knowledge in GMPs, FDA compliance, and ISO 13485/PISO standards
- Competence in environmental monitoring, contamination control, and root cause analysis (RCA)
Physical Requirements:
- Ability to stand, walk, and lift occasionally up to 25 pounds
- Capability to gown and work in controlled manufacturing environments
Language:
- Fluency in English required; proficient in other languages beneficial
Corporate commitment to driving continuous improvement and a genuine passion for advancing healthcare/service excellence.
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