Provide on-the-floor Quality Assurance (QA) oversight & support to ensure compliance to GMP through the production & warehouse areas.
Requirements:
Requires Master degree in Science, Engineering, Management, or a related field + 2 years of Quality Assurance experience. Alternatively, employer will accept a bachelor degree in the above-listed fields + 5 years of Quality Assurance experience. Must have full term of experience with the following: GMP Compliance Oversight - On-the floor QA surveys ensuring adherence to Good Manufacturing Practices across ISO-classified cleanroom environments (ISO-5, ISO-7, ISO-8); Deviation, Non-Conformance & CAPA Investigations – Leading & documenting investigations tied to deviations, GMP violations, & implementing corrective/preventive actions; Batch Record Review & Final Product Disposition – Review & approval of Manufacturing Production Records (WRs, BMRs, IQ-2s) & Electronic Batch Records for lot release; Quality Documentation & Change Control – Authoring, reviewing, & approving SOPs, risk assessments, protocols, & document change requests using systems like Viva-Vault & Gvault; Data Analysis for Continuous Improvement – Using metrics & FMEA to identify trends, support root cause analysis, & drive process improvements; Quality Systems & Software Proficiency – Skilled Oracle EBS, Gvault, MES, Viva-Vault, LIMS, & Equipment Monitoring Systems for compliance tracking & documentation; Material Flow & Line Support Manufacturing – Supporting production operations, verifying equipment calibration, & ensuring proper material movement & documentation.
Compensation:
Annual salary range for this position is $156,437 to $168,500. Compensation will vary depending on experience & qualifications, & for benefits visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing.
Application Instructions:
To apply for this role: [email protected] & ref job code SA017.
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