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. Available for non-standard shift which includes nights and weekends.
Competencies / Skills:
- Quality Professional with Manufacturing Process Audit and Batch Record Review experience. In addition, some knowledge or to be familiar with DAI process, PASx/MES application, MAXIMO, SAP and LIMS.
- Designee for QA manager on local CCRB.
- Review and approve EMS/BMS alarms.
- Initiate and lead cross functional teams.
- Enhanced skills in leading, influencing and negotiating.
- Strong knowledge in area of expertise.
- Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development.
- Demonstrate ability to interact with regulatory agencies.
- Strong communication (both written and oral), facilitation and presentation skills.
- Strong skill in working independently and to effectively interact with various levels.
- Advanced data trending and evaluation.
- Ability to evaluate compliance issues.
Education:
Bachelor's degree and 5 years of directly related experience or Associate's degree and 10 years of directly related experience or High school diploma / GED and 12 years of directly related experience.