Eurofins is looking to improve the quality and timeliness of data provided to clients, requiring enhanced investigation writing, root cause analysis, and adherence to quality metrics and CAPA implementation.
Requirements
- Familiarity with GMP and Medical Device Quality System (21 CFR Part 820 and ISO 13485)
- Knowledge of general requirements for the competence of testing and calibration laboratories (ISO/IEC 17025)
- Experience in handling/supporting external audits (agency and client)
- Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
Responsibilities
- Work with the laboratory and support groups to improve quality metrics, and enable CAPA implementation.
- Also support the technical and supports groups with investigation writing and review, including thorough root cause analysis
- Technical writing and review; tracking action items and driving to completion; ability to identify trends in recurring events.
- Perform higher level QA tasks including but not limited to: major investigation writing/review, in-depth root cause analysis, data trending/analysis, supplier audits, internal audits, validation/change control writing/review, batch record/EM report review, assist with agency inspections, review/write QAU procedures.
Other
- Delegate responsibilities and project ownership to direct reports.
- Provide follow-up, support, and constructive feedback for delegated tasks.
- Make employee development a top priority – project/department cross training, technical skills development, involvement/ownership, job plans in place, expectations/goals clearly communicated.
- Be available and coach direct reports though challenges, without doing the work for them.
- Demonstrate professional behavior and support upper management in initiatives to improve quality/productivity.
