Specialist QA
4 weeks ago
Candidates qualifications / expertise;
• 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.
Requirements Education & Years of experience required;
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
or High school diploma / GED and 12 years of directly related experience.
Educational background in Life Science and/or Engineering.
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