Quality Specialist
Flexible & Integrated Technical Services, LLC
- Yauco, PR
- Permanente
- Tiempo completo
- Bachelor’s Degree in Life Sciences or Engineering and previous exposure in Investigation activities within the Pharmaceutical or Medical Devices industry.
- Excellent reading, writing, and speaking skills in Spanish and English.
- Shift: Administrative and according to business needs
- Experience in:
- CAPA Experience
- Investigations process
- Non-Conformance
- Root Cause Analysis
- Support Quality Notification Investigation Supervisor, while supporting Quality Notification Investigation staff at all levels.
- Work closely with the manufacturing and technical service to troubleshoot and solve problems.
- Authors investigations (deviations/nonconformance and/or complaint) and formulates CAPA’s associated with the event, if required.
- Work closely with cross-functional partners to remediate events and/or CAPA's necessary to close out the investigation.
- Ensured that all investigations /complaints are drafted to meet site specified timelines and are completed prior to release of associated product(s), if product impacted.
- Ensured and coordinated involvement of cross-functional teams with appropriate expertise, when necessary, based on the investigation to be performed.
- One of these is the excellent, unmatched, never-before-seen customer service of our team (trust us, you’ll be amazed). However, that’s not all we have to offer. Talk with us to find out!