When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.
 
Location/Division Summary
High Point, NC

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, and other areas as applicable. Incumbents will accomplish this by working directly with colleagues in the planning and execution of activities. The QE will employ working knowledge of manufacturing processes, regulations and quality management principles in the conduct of his/her responsibilities. Further, he/she will collect, evaluate and interpret performance indicator data to identify sub-standard performance, compliance gaps and/or performance improvement opportunities. The QE will work with colleagues to implement necessary process improvements and change.

What you will do

The QE has the authority to 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.

The QE will have the responsibility of working 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. 

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

Other duties as assigned.

How you will get here

EDUCATION AND EXPERIENCE:

BS in Scientific/Technical discipline with a minimum of 5 to 8 years of related experience in the pharmaceutical industry with 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