Inteldot has over 10 years in the life science industry with allocations a cross Puerto Rico, United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.
Description:
As a Quality Assurance Specialist you'll lead approval for MPs, validations, and incident triage. Approve reports, release systems, and represent QA in NPI. Own site procedures, lead investigations, and support automation. Approve Work Orders, alarms, NC investigations, CAPA records, change controls, ensuring lot disposition for shipment. Drive excellence and regulatory compliance.
Competencies / Skills:
- Demonstrated experience in Manufacturing Process Audit and Batch Record Review.
- Knowledgeable in DAI process, PASx/MES application, MAXIMO, SAP and LIMS.
- Active participation in the triage process to assess and prioritize quality-related issues.
- Manage Change Controls and deviations for review and approval as QA contact.
- Expertise in Validations and Process Development.
- Non-Standard Shift
Education:
Bachelor's degree and 5 years of related experience or Master's degree and 3 years of related experience