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Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Job Summary

At Thermo Fisher Scientific Inc., we are looking for a motivated Deviation Specialist III to join our United States team. This key position plays a vital role in maintaining our operations' quality and regulatory compliance standards. As a Deviation Specialist, you will play a crucial role in identifying, documenting, investigating, and resolving deviations from standard procedures, protocols, and regulatory requirements. Your proficiency is vital for managing any discrepancies flawlessly, by implementing corrective and preventive actions (CAPAs) effectively.

Key Responsibilities

Deviation Management

+ Recognize and detail departures from standard operating procedures (SOPs), quality standards, or regulatory guidelines.

+ Perform detailed investigations to determine the root cause of deviations.

+ Work collaboratively with diverse teams to develop and deploy strategies for addressing and avoiding issues (CAPAs).

Documentation and Reporting

+ Maintain accurate and detailed records of all deviations, investigations, and CAPAs.

+ Prepare and present deviation reports to management and regulatory authorities as required.

+ Make sure documentation is finalized following Good Documentation Practices (GDP).

Ensuring Compliance and Upholding Quality Standards

+ Address all deviations in alignment with company policies, industry standards, and governing guidelines.

+ Participate in internal and external audits and inspections, providing vital documentation and information related to deviations.

Continuous Improvement

+ Analyze deviation trends and provide insights for continuous improvement initiatives.

+ Engage in training sessions to improve knowledge and skills concerning deviation management and quality assurance.

Qualifications

+ Bachelor’s degree in a relevant field such as Life Sciences, Engineering, or Quality Management.

+ 3 years of experience in quality assurance, deviation management, or a related role in the industry.

+ Knowledge of regulatory requirements (e.g., FDA, EMA, ISO) and industry standards.

+ Strong analytical and problem-solving skills.

+ Excellent communication and interpersonal skills.

+ Proficiency in systems for managing quality (QMS) and related software applications.

Preferred Qualifications

+ Accreditation in Quality Management (e.g., Six Sigma, ASQ).

+ Experience with electronic documentation systems.

+ Familiarity with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).

Working Conditions

This role involves work in office, lab, and warehouse environments. It requires performing physical tasks and may involve exposure to noise and temperature changes.

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.

*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 non-disability related technical issues will not receive a response.

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.