Senior Quality Specialist

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.

Position Summary: Responsible for designated quality assurance and quality control activities and to ensure compliance to established standard operating procedures and regulatory guidelines. The associate is to ensure that supplies, facility and processes are maintained to cGMP standards.

Essential Duties and Responsibility:

• Responsible for compliance with applicable Corporate and Divisional Policies and procedures, including local and international regulations applicable to clinical trials supply chain activities
• Maintain a good understanding of local and international regulations, and keeping abreast with regulatory changes and developments
• Provide consultative guidance on quality related matters to clients and internal associates
• Document Control Management
• Conducts internal/supplier audits according to SOP requirement and assist in regulatory, supplier and client audits
• Perform pre and post review and approval of production batch records
• Perform pre and post review and approval of label printing records
• In-Process Inspection Responsibilities for production and label printing jobs
• Management of non-conformances (deviations, complaints and quality investigations) and related corrective and preventive actions
• Responsible for quality compliance of controlled temperature shipments
• Approval of components and material specifications
• Responsible for the release of client/Fisher supplied materials
• Prepare new and update existing job related Standard Operating Procedures (SOPs)
• Assist in the QA/GMP training of employees across the company
• Participate in department systems development initiatives to improve regulatory and quality efficiency and compliance
• Perform ad-hoc duties as requested by line management

Minimum Qualifications

Degree in any discipline

At least 5 years of relevant experience

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

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