Job Title: Engineer III QA
Requisition ID: 117024BR
Site Location: Greenville, NC
When you join us at Thermo Fisher Scientific, you'll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of more than $24 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.
How will you make an Impact?
You 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, you will provide quality guidance and expertise for implementation of practical process improvements and continuous improvement initiatives.
What will you do?
- 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
- Participate in rapid response and quality guidance for deviation events
- Ensure escalation of deviation events to the appropriate area and quality management
- Identification of continuous improvement opportunities
- Quality batch record review as designated by supervision
- Perform quality review and approval of procedures, training documents, and forms
- Quality review and approval of deviation and change control
- Root Cause Analysis to support deviation investigations
- Participates in practical process improvement initiatives
- A minimum of 2-3 years' 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 day shift schedule
- Primary responsibilities require consistent production floor presence which necessitates physical fitness for prolonged standing, walking, and repetitive bending, proficiency in both aseptic and non-aseptic gowning, and knowledge of aseptic technique.
Posting ID: 556644907Posted: 2020-05-21