DESCRIPTION
Perform one or more of the following duties and responsibilities in support of Amgen’s Quality Assurance program under minimal supervision:
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
Perform review, approval and tracking of cGMP processes, procedures, testing (methods) in manufacturing, documents and records, batch record review, MES, EBR, SAP, Trackwise; including but not limited to Deviation’s, CAPAs, and validations

EDUCATION

Master’s degree  and 3 years of directly related experience or Bachelor’s degree  and 5 years of directly related experience

Educational background in Life Science and/or Engineering.

REQUIREMENTS
• 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.

Ultimate Solutions Corp is an Equal Opportunity Employer.