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Ncr Quality Specialist Iii

1 month ago

Middletown, United States Thermo Fisher Scientific Full time

As 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 Package**

Review our company’s Total Rewards

Medical, Dental, & Vision benefits-effective Day 1

Paid Time Off & Holidays

401K Company Match up to 6%

Tuition Reimbursement - eligible after 90 days

Employee Referral Bonus

Employee Discount Program

Recognition Program

Charitable Gift Matching

Company Paid Parental Leave

Career Advancement Opportunities

**Location/Division Specific Information**:
Middletown, VA

Speciality 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**?

**Education**:
Bachelor’s degree in Biological Sciences or a related field

**Experience**:

- 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 assistance**:
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

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