Qa Specialist

Perform one or more of the following duties and responsibilities in support of Quality Assurance program under minimal supervision.
Duties/Responsibilities:
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
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.
Education/Experience:
Bachelor's Degree with 5 or more years of directly related experience
Job Types: Full-time, Contract
Schedule:
8 hour shift
Day shift
Monday to Friday
Education:
Bachelor's (Required)
Experience:
Quality assurance: 5 years (Required)
Change Control/Deviations: 5 years (Preferred)
Validations: 5 years (Preferred)
Language:
Bilingual (English/Spanish) (Preferred)
Ability to Commute:
Juncos, PR 00777 (Required)
Work Location: In person