Thermo Fisher Scientific
Quality Specialist I
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Quality Specialist I
Quality Specialist I - Manufacturing Quality Compliance Thermo Fisher Scientific
Work Schedule:
- 7.5-hour shifts
Environmental Conditions:
- Office-based
About the Role
As part of the Thermo Fisher Scientific team, discover meaningful work that drives global impact. Join colleagues dedicated to our Mission: enabling customers to make the world healthier, cleaner, and safer. We empower our teams to achieve personal career growth while tackling world-changing challenges—from environmental sustainability to advancing healthcare innovations.
Role Description
Join our high-performing team at Thermo Fisher Scientific to ensure quality compliance across manufacturing operations while advancing our mission of enhancing global well-being. As a Quality Specialist I, you will:
- Deliver essential quality oversight through rigorous documentation review, process monitoring, and cross-functional collaboration.
- Maintain Good Manufacturing Practice (GMP) compliance, investigating quality events and driving continuous improvement initiatives.
- Contribute to delivering life-changing products in a collaborative environment akin to the following:
Key Responsibilities
Quality Assurance & Compliance:
- Review, edit, and approve GMP documentation, batch records, and quality control (QC)/quality assurance (QA) records adherence to regulatory and internal standards.
- Ensure compliance with international quality standards, including ISO regulations.
Process Improvement & Problem-Solving:
- Lead process analytics, process monitoring, and nonconformance reporting, integrating tools like CAPA (Corrective and Preventive Action) and change control systems.
- Investigate quality events, perform root cause analyses, and recommend systematic solutions.
Collaboration & Documentation:
- Collaborate with cross-functional teams, including development, engineering, regulatory, and production, to enhance product and process quality.
- Maintain precise, comprehensive technical documentation and reporting aligned with internal and external quality standards.
- Contribute to leading-edge scientific projects, driving operational excellence while supporting personal growth.
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Compliance & Regulatory Support:
- Support environmental monitoring and contamination control measures.
- Advise on regulatory best practices, maintaining vigilance for adherence to industry standards.
Requirements
Academic Background & Experience:
- Bachelor’s Degree in Chemistry, Biology, Engineering, Life Sciences, or a related scientific field (preferred).
- 2+ years of experience in a regulated manufacturing environment (preferably biopharma, pharma, or lab science).
Certifications (Advantageous but Not Mandatory):
- ISO auditor certification or Six Sigma (Green/Black Belt).
Technical & Regulatory Skills:
- Extensive knowledge of ISO-specific regulations (e.g., ISO 9001, ISO 13485) and Good Manufacturing Practice (GMP) protocols.
- Proficiency in Quality Management Systems (QMS) tools, including CAPA, Change Control, and QMS software.
Writing & Analytical Competencies:
- Excellent documentation and technical writing skills.
- Strong proficiency in Microsoft Office and data analysis.
Soft Skills:
- Analytical & problem-solving expertise with meticulous attention to detail.
- Outstanding verbal/written communication, ensuring clarity across diverse audiences.
- Ability to work independently, self-motivate, and collaborate across departments.
Stipulations & Physical Ability:
- Ability to gown and operate within controlled manufacturing environments, as required.
- Ability to stand, walk, and lift up to 25 pounds occasionally.
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Skilled Languages
- Fluency in English required.
- Additional language skills are highly beneficial.
Culture & Commitment
- Strong commitment to a quality-focused culture and driving continuous improvement.
- Shared commitment to Thermo Fisher’s values of innovation, integrity, and service.
About Thermo Fisher Scientific
We are the world leader in serving science. With over USD 40 billion in annual revenue, our global teams deliver transformative solutions—innovative technologies, convenience, and pharmaceutical services—under our iconic brands including Thermo Scientific, Fisher Scientific, Applied Biosystems, and PPD.
By joining us, you join the story of purpose. Imagine contributing to game-changing new discoveries, from life-saving therapies to ensuring food safety to reversing environmental harm. Our teams are driven by jobs of meaning, exceptional innovation, and unparalleled career growth.
Experience our environment today: "What story will you tell?"
Legal Disclosures
Thermo Fisher Scientific is an Equal Opportunity Employer All qualified candidates will be considered for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age, or disability status.
We will ensure that individuals with disabilities receive reasonable accommodation to:
- Participate in the job application/interview process.
- Perform essential job functions.
- Access benefits and privileges of employment.
To arrange such accommodations, please contact us.
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