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Job DescriptionAs part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.Excellent Benefits PackageReview our company’s Total Rewards (https://jobs.thermofisher.com/global/en/total-rewards)Medical, Dental, & Vision benefits-effective Day 1Paid Time Off & Holidays401K Company Match up to 6%Tuition Reimbursement – eligible after 90 days!Employee Referral BonusEmployee Discount ProgramRecognition ProgramCharitable Gift MatchingCompany Paid Parental LeaveCareer Advancement OpportunitiesLocation/Division Specific InformationMiddletown, VASpeciality Diagnostics Group (SDG)How will you make an impact?The Quality Specialist III will monitor/address/track quality issues that arise from Customer Inquiry (CI), Non-Conformance (NCR) or from Internal/External quality system audits. This position will assist the QA Manager and product line/QS process owners with Corrective/Preventive action (CAPA) projects to ensure timely and effective completion of required activities.What will you do?The duties and responsibilities include, but are not limited to the following:
Oversight of the NCR process associated with all aspects of operational processing and batch release
Responsible for the management and closure of different investigations, DRs, NCRs, and Issues.
Lead and/or facilitate cross-functional team discussions with the goal of achieving robust and detailed root cause investigations
Drive and lead teams in continuous improvement efforts - identify and address root cause situations, and build systems to prevent and correct issues. Conducts financial analysis to forecast and assess project impact.
Responsible for determining non-conforming products and materials disposition and ensure all nonconforming product(s) are identified and removed from use.
Ensure completion and accuracy of all associated quality records related to nonconformance and CAPA reports.
Perform computer operations for data entry and provide tracing/trending reports.
How will you get here ?EducationBachelor’s degree in Biological Sciences or a related fieldExperience
Three (3) years of experience in a Quality regulated environment
Detailed knowledge of ISO 13485 and GMP regulations which govern a medical device and diagnostics manufacturing.
Investigational skills.
Knowledge of CAPA requirements.
Tracking and trending tools and reporting techniques
Knowledge, Skills, Abilities
Solid understanding of MS Office software, including Word, Excel, and PowerPoint,
Lead meetings and obtain consensus among cross functional teams
Provide accurate QS tracking and trending reports.
Good procedural writing skills a plus.
Exercise independent discretion and judgment in execution of duties.
This position does not have relocation assistanceOur 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 (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-thermo-fisher-scientific) . 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.Apply today! http://jobs.thermofisher.comThermo 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 AccessJob 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.