Staff QA Engineer

Thermo Fisher Scientific - Greenville, NC3.5

Full-time
Job Description

Staff QA Engineer

When youre part of the team at Thermo Fisher Scientific, youll 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 youll be supported in achieving your career goals.

Division
Pharmaceuticals Services Group

What you will make an impact

Provides technical leadership and Quality oversight for a Sterile Manufacturing Environment in association with specific aspects of Quality to ensure compliance with regulations that govern pharmaceuticals. Ensures full compliance of the Company can operate without regulatory actions that impede product quality, cause product stoppages or reduce customer satisfaction.

What you will do

Works on issues of moderate to sometimes high complexity in regards to compliance of processes and product within facilities, equipment, manufacturing and support areas. Makes decisions while taking into account level of risks in regards to compliance and product quality.

Lead projects of moderate to high complexity in scope and compliance-related challenges to implement procedures and processes to meet changing regulations.

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

Processes and projects of moderate complexity, perform compliance assessments, make decisions regarding regulatory requirements, write new procedures and ensure adherence to current regulations.

Ensures quality of methods, processes, materials and products by providing coordination and review of group operations, staff training, and the assessment/improvement of systems and processes.

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

Acts as a technical resource for support of systems and new product introduction by proactively interpreting regulatory and compliance requirements, establishing and maintaining systems.

Performs QA batch disposition (release decisions)

Performs other duties as assigned

How you will get here
Education

Bachelors degree in a scientific or related field is required.

Experience

Five years of experience in the pharmaceutical industry is preferred.

Knowledge, Skills, and Abilities

Outstanding attention to detail and organizational skills.

Self-starter, mature, independent and dependable.

Ability to work in a fast paced environment under pressure, able to multi-task and is results-oriented.

Demonstrates ability to maintain a high degree of confidentiality.

Effective time management and prioritization skills. Requires discretion and independent judgment.

A very high degree of interpersonal skills to establish and maintain effective working relationships with employees and the public, including tact to handle sensitive matters. Highly effective verbal and written communication skills.

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.

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.