Thermo Fisher Scientific Inc. is looking to drive quality execution across sterile operations, including manufacturing, filling, packaging, and inspection, to ensure compliance with cGMPs and site procedures.
Requirements
- Previous experience in pharmaceutical industry; preferably aseptic or steriles processes strongly preferred, experience in other GMP environments may be considered (i.e. ISO 9001)
- Ability to capture data, analyze & troubleshoot process issues, equipment problems along with production leadership
- Ability to troubleshoot process and equipment issues
- Technical Writing experience
- Professional certifications (ex: CQA) and training (Six Sigma) are a plus
- Experience with quality assurance or quality control systems
- Knowledge of cGMPs and site procedures
Responsibilities
- Perform daily quality assessments of facility, personnel, and documentation both classified and non-classified areas to uncover errors or deficiencies, assure quality, and compliance per site procedures and cGMPs.
- Daily interaction with employees to assist with troubleshooting, documentation corrections/notes, and guidance with aseptic technique
- Champions quality culture by aiding personnel in understanding application of policies and controls
- Participates in RAPID event response and provides quality guidance for deviation events
- Advances deviation events to the appropriate area and quality management
- Performs quality review and approval of procedures, training documents, and forms of moderate to high complexity
- Performs quality batch record review
Other
- Bachelor’s degree, preferably in technology, engineering or microbiology related field required.
- 5+ years of experience with previous experience in Quality Assurance or Quality control or Operations/Manufacturing required
- Ability to lead, support & empower a team/peers
- Hard-working, demonstrated ownership & responsibility;
- Primary responsibilities require consistent production floor presence which necessitate physical fitness for prolonged standing, walking, and repetitive bending, and aseptic and non-aseptic gowning.
