Quality Assurance Expert
vor 2 Wochen
We are seeking a highly skilled Quality Assurance Expert to join our team at Thermo Fisher Scientific. This role offers an exciting opportunity for an individual to contribute to the success of our company and advance their career in quality assurance.
Job OverviewAs a Quality Assurance Expert, you will play a critical role in ensuring the quality of our products and services. You will work closely with cross-functional teams to implement and maintain quality systems, conduct audits, and provide training to colleagues.
About the RoleThe successful candidate will have a degree in a scientific field or equivalent experience in quality control/quality assurance. They will also have GxP training or experience, as well as excellent communication and organizational skills. Proficiency in English and German is essential for this role, with a high level of accuracy and efficiency required.
Responsibilities- \
- Review executed batch records and create certificates of packaging
- Support QA pre-approval by reviewing and approving pre-executed batch documentation, finished product with TOE and label components, change orders, packaging and labeling requests, job specifications, packaging orders, LINKS reports, randomizations, SPA, and supporting documentation
- Liaise with project managers to ensure documents meet customer and regulatory requirements (including Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) guidelines) and Fisher Clinical Services Standard Operating Procedures (SOPs)
- Coordinate internal communication regarding scheduling and completion of documentation reviews and approvals
- Provide information internally regarding the documentation review and approval process to support project planning
- Support improvement of documentation right first-time metrics
- Ensure any deviations or quality issues are appropriately documented
- Input or analyze data for quality metrics
- Inform supervisor of quality issues
- Maintain accurate records for all work activities
- Train and introduce new team members and other FCS departments (CS, CSOS, etc.)
- Organize and execute GMP document archival (internal/external)
- Support the larger Quality department, which may include tasks such as participation in Practical Process Improvement or other projects, review and disposition decisions according to agreed customer process for transport deviations and temperature excursions, review and approval of Pharma Unit Trackwise problem reports (PRs), and acting as a customer quality contact
- \
- Experience or degree in pharmaceutical industry, quality control/quality assurance, medication handling, scientific field, or equivalent
- GxP training or experience
- Demonstrated ability to perform detail-oriented tasks
- Bachelor's degree in science or equivalent or GxP training or previous experience in pharmaceutical industry, quality, medication handling, or scientific role
- Excellent communication and organizational skills
- High level of accuracy and efficiency
- Ability to express detail in simple terminology, both written and verbal
- Command of English and German at professional level
Salary: $80,000 - $110,000 per year, depending on location and experience.
At Thermo Fisher Scientific, we offer a dynamic work environment and opportunities for growth and development. If you are a motivated and experienced quality assurance professional looking for a new challenge, please apply today.
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