Thermo Fisher Scientific Sr. Quality Associate in Greenville, North Carolina
When you are part of the team at Thermo Fisher Scientific, you will do important work, and you will be valued and recognized for your performance. With talented managers and inspiring coworkers to support you, you will find the resources and opportunities to make significant contributions to the world.
This position will be responsible for ensuring quality execution of sterile operations with respect to manufacturing, filling, packaging and inspection, and associated non batch specific activities in the Steriles facility for both commercial and product development services products. Additionally, this position will provide quality guidance and expertise for implementation of practical process improvements and continuous improvement initiatives. Primary responsibilities require consistent production floor presence which necessitate physical fitness for prolonged standing, walking, and repetitive bending, proficiency in both aseptic and non-aseptic gowning, and knowledge of aseptic technique.
This is a rotating night shift position.
Perform daily quality assessments of facility, personnel, and documentation both classified and non-classified areas to uncover errors or deficiencies and ensure compliance to site procedures and cGMPs.
Daily interaction with personnel to assist with troubleshooting, documentation corrections/notes, and guidance with aseptic technique
Fosters quality culture by aiding personnel in understanding application of policies and controls
Participates in rapid response and provides quality guidance for deviation events
Ensures escalation of deviation events to the appropriate area and quality management
Aids in identification of continuous improvement opportunities
Performs quality batch record review as designated by supervision
Performs quality review and approval of procedures, training documents, and forms as designated by supervision
Performs quality review and approval of deviation and change control as designated by supervision
Participates in Root Cause Analysis to support deviation investigations
Participates in practical process improvement initiatives
Previous experience in Quality Assurance or Quality control
Previous experience in pharmaceutical industry
Bachelor’s degree, preferably in engineering or microbiology related field
Ability to troubleshoot process and equipment issues
Self-driven, demonstrated ownership & responsibility; Ability to lead, support & motivate a team
Technical Writing experience
Professional certifications (ex: CQA) and training (Six Sigma) is a PLUS
Equivalent combinations of education, training, and relevant work experience may be considered
Position requires 12 hour night shift schedule
At Thermo Fisher Scientific, each one of our 65,000 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.
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.