Quality Associate III

Thermo Fisher Scientific - Greenville, NC3.5

Job Description
When you join us at Thermo Fisher Scientific, youll 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.

Job Summary

Provides direct quality support to ensure compliance with regulations that govern pharmaceuticals.

Ensures the site can operate without regulatory actions that impede product quality, cause product stoppages, or reduce customer satisfaction.

Essential Functions

1. Complies with all job-related safety and other training requirements. Employees responsibility to work in a safe and responsible manner in order to create an injury-free and incident-free workplace.

2. Processes and projects of moderate complexity, perform compliance assessments, make decisions regarding regulatory requirements; ensures adherence to current regulations with little dependence on others.

3. Provides leadership and team participation as assigned for assignments related to quality initiatives and compliance improvements, product transfers, facility expansions, etc.

4. Performs document reviews and made determinations as to whether work performed meets current procedures and regulatory expectations. Communicates and coordinates with other departments as required to resolve issues and compliance concerns detected during review.

5. Conducts risk assessments and take appropriate actions during quality oversight activities (e.g. during review/approval) to ensure adequate controls in relation to the level of product quality, safety and business risks.

6. Performs QA batch disposition (release) decisions.

7. Complies with all job-related safety and other training requirements.

8. Performs other duties as assigned.

Bachelors degree in related field (Computer science, Chemistry, Biology, or other technical or physical/life science) is required.
Three years of relevant experience is preferred.
Equivalent combinations of education, training, and relevant work experience may be considered.
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 missionenabling our customers to make the world healthier, cleaner and safer.
If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here 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.