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
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