Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer.
Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
Location / Division
High Point, NC / Pharma Services Group
How you will make an impact
The Quality Engineer is a technical professional in the Quality organization that has the delegated responsibility of directly ensuring the quality work outputs and compliance of work practices for personnel from commercial production, validation, and plant engineering. The QUality Engineer will work directly with colleagues in the planning and execution of activities while employing working knowledge of manufacturing processes, regulations and quality management principles. The Quality Engineer will collect, evaluate and interpret performance indicator data to identify sub-standard performance, compliance gaps and/or performance improvement opportunities.
What you will do
Author, participate in and or approve Standard Operating Procedures/Work Instructions, forms, test procedures, validation/qualification protocols and summary reports, internal audits, training, technical investigations, and other documents and activities requiring Quality Assurance involvement as applicable.
Work across functional lines to facilitate project teams in the implementation of quality or compliance improvement. He/she is viewed as a subject matter expert on operational quality, pharmaceutical manufacturing work process design and control, and technical problem solving.
As such he/she is highly visible and demonstrates highly effective oral and written communication skills. Create a team approach to the management of quality and compliance is a critical success factor for the incumbent.
Applies an advanced knowledge of regulatory compliance requirements and commercial pharmaceutical operations quality principles in the operations to which he/she is assigned, notably softgel manufacturing, validation, engineering and associated activities.
Works on complex problems in which analysis of situations or data requires in-depth evaluation of various factors.
Leads cross functional teams engaged in quality/compliance improvement activities.
Facilitates the increased quality/compliance knowledge of assigned area.
Serves as primary resource and technical subject matter expert in areas of troubleshooting, problem solving, process/method improvement, and the assuring the quality and compliance of these activities.
Directs complex technical and/or organizational problem solving activities using proven tools such as statistical analysis, screening experiments, Design of Experiments (DOE) etc.
Identifies negative trends in quality/compliance and ensures correction of root causes of deficiencies.
Reviews and approves Standard Operating Procedures, study design plans, manufacturing processes, qualification and/or validation protocols, investigational test plans, investigation reports, change control requests and other operational documentation where QA review and approval are required
Makes sound judgments and decisions and provides proper advice on issues of regulatory compliance and/or work product quality nature
Drives the implementation and enhancement of policies and procedures consistent with regulatory policies, customer expectations, and fundamental principles of quality
Assure the identification and implementation of advanced quality and compliance management principles and techniques resulting in positive changes in operations
Operates with minimal level of direct supervision
Assumes leadership role in managing projects, develops technical and organizational recommendations with significant impact, and uses influence to drive ongoing improvement of quality and compliance
How you will get here
EDUCATION AND EXPERIENCE:
BS in Scientific/Technical discipline
A minimum of 5 to 8 years of related experience in the pharmaceutical industry
Commercial manufacturing quality assurance experience and demonstrated working knowledge of scientific principles
An equivalent combination of education and experience may be substituted
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.
Apply today! http://jobs.thermofisher.com
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.
Thermo Fisher Scientific Inc.