Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

Position Summary:

As a Quality Specialist III with Thermo Fisher Scientific Inc., you will be at the forefront of establishing an exceptionally high standard of quality within our organization. This outstanding opportunity allows you to collaborate with world-class professionals, ensuring our products and services meet and exceed industry standards. You will play a crucial role in driving quality initiatives and encouraging an inclusive, collaborative environment.

Key Responsibilities:

• Coordinate CAPAs by guiding owners in conducting investigations and implementing risk-based corrective actions. Keep track of progress using MasterControl's CAPA module and report metrics to the manager. Implement Preventive Actions to improve quality.
• Assist with launching Quality Plans (QP) in MasterControl, review for completeness, enable Impact Assessment reviews, set implementation plans, follow through, review action completion, and report metrics.
• Implement the Training Annual Operating Plan (Training AOP) by choosing appropriate content for effective trainings, establishing schedules, delivering training sessions, and tracking metrics.
• Ensure Quality participation in Practical Process Improvement (PPI) by attending Tier Board meetings, providing oversight during Kaizen events, ensuring documentation through CAPA generation, and reporting metrics.
• Support the Quality Department by updating SOPs, participating in audits, and completing Quality Evolution Projects.
• Lead and/or participate in related team meetings and/or performance reviews, as needed. Lead and provide support during Management absence, as needed.
• Revise and optimize metrics reporting and Management Review.
• Manage routine review, training and updating of department standard operating procedures (SOPs) as necessary.

• Bachelor's degree in Biological Sciences or a related field.
• 3+ yrs of proven experience in Quality Systems/Assurance in a regulated environment.
• Proficiency in crafting presentations, working with spreadsheets, preparing reports, and documents.
• Proficient in MS Word, Excel, and PowerPoint.

• Background in diagnostics.
• Knowledge of ISO and GMP regulations, statistical process controls, GMP CAPA requirements, and tracking and trending tools.
• Ability to provide accurate tracking and trending reports, write procedures, exercise independent judgment, empower others, establish effective relationships, communicate effectively, and maintain confidentiality.

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount