Thermo Fisher Scientific Engineer/Scientist I, QA in Grand Island, New York
About Thermo Fisher Scientific :
When you join us at Thermo Fisher Scientific, you’ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 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. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services. At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
Responsible for maintaining the Quality Management System in a safe, quality and customer focused manner. This individual will act as an “on the floor” subject matter expert within Quality Engineering Group to support the on time release of products following Good Manufacturing Practices.
We are seeking a self-motivated individual with strong communication, leadership and operational skills to coordinate and execute planned and systematic activities implemented in a quality system so that quality requirements for products, processes, systems or equipment will be fulfilled, and ensure that products manufactured meet internal, customer and regulatory requirements
Key Objectives of the role:
Upholds departmental standards as required in a GMP environment
Aids in management of the site Quality Management System including change control (ECR/ECO), complaint handling, change control, internal auditing, management reviews, training, and manufacturing area support
Provides reports and monitors investigation progress to ensure adherence to predetermined timelines
Performs statistical analysis to analyze trends, and works with manufacturing to investigate, conduct root cause analysis, recommend corrective actions for processes and products and to contribute to and track data to support at the site level (e.g. yield improvements, CAPA, complaint and scrap reduction)
Leads teams to conduct root cause analysis
Trends and assesses data to track program effectiveness and proactively identify areas of risk
Drive a culture of continuous improvement by employing Practical Process Improvement concepts
Reports all non-compliance and support, engage in, and potentially lead teams assigned to making improvements.
Provides feedback and coaching to team members on daily work tasks
Multi-tasks efficiently in a high-paced environment
Focuses on team objectives to meet customer expectations
Supports training and cross-training efforts for team development
Minimum Qualifications (must have):
3-5 years of work experience in a direct Manufacturing setting or combination of experience and education
Strong written, verbal, and organizational skills, and the ability to work independently with cross-functional teams.
High degree of proficiency in writing protocols and reports.
Ability to work in a high paced team environment, prioritize multiple workflows and projects.
BS/MS in relevant scientific discipline and 5+ years’ experience in Quality Control, Quality Assurance or equivalent combination of education and experience.
Excellent computer skills, display specific expertise in Excel
Quality standards (e.g., 21 CFR Part 820 and ISO 13485)
Preferred Qualifications (nice to have):
Bachelors’ degree in Science related studies
Behaviors including: problem solving, professional demeanor, multi-task capabilities in high paced environment, motivational and team building skills, presentation and training skills, and delegation skills.
Ability to work independently and in a group setting with little direction.
What Thermo Fisher Offers to Employees:
Medical, Dental, and Vision benefits effective on first day of employment
Paid Time Off – Eligible to accrue up to 3 weeks of Paid Time Off (PTO), pro-rated based on start date
401(K) Retirement Plan – Company Matching Contribution up to 6%
Shift Premium for 2nd and 3rd shift employees
If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here at https://jobs.thermofisher.com/page/show/eeo-affirmative-action-statement#accessibility for further assistance.
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.