Specialist Qa

Specialist QA with experience in regulated industry to:
Perform Trackwise system queries, deviations
Participate in triage process
Perform oversight of the process and procedures/GMP tasks
Manage Change Controls and deviations for review and approval as QA contact
Work with operations to resolve basic compliance discrepancies
Requisitos:
Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience or Associate's degree and 10 years of directly related experience (Educational background in Life Science and/or Engineering).?
Knowledge in Validations and Laboratory area and equipment.
Strong organizational skills, including ability to follow assignments through to completion.
Enhanced skills in leading, influencing and negotiating with the ability to interact with regulatory agencies and evaluate compliance issues.
Microsoft Office spreadsheet and application skills and presentation knowledge.
Strong communication (both written and oral), facilitation and presentation skills. Fully Bilingual in English and Spanish.
Validated skill in working independently and to optimally interact with all levels throughout the organization.