QA Specialist II
Gilead Sciences
4 months ago
Remote friendly (San Francisco Bay Area)
United States
$102,085 - $132,110 USD yearly
Operations
QA Specialist II (Global Logistics Quality)
Responsibilities:
- Review and approve deviations, investigations, and CAPA records associated with Global Logistics activities.
- Support change controls related to distribution processes, transportation lanes, and 3PL operational activities.
- Conduct quality reviews of distribution and operational documentation (e.g., shipping records, environmental monitoring, temperature excursions).
- Partner with QA colleagues to ensure compliance with GDP, GMP, and applicable regulatory requirements.
- Provide QA oversight of global 3PL partners, including assessment of operational compliance, quality performance, and adherence to Gilead standards.
- Monitor and review logistics data to identify quality trends or potential process improvements.
- Contribute to routine quality metrics reporting and partner with Logistics to address identified gaps.
- Participate in development, revision, and maintenance of SOPs related to distribution and logistics operations.
- Support internal audits and external inspections pertaining to distribution activities.
- Ensure consistent application of quality policies, procedures, and industry best practices across the logistics network.
- Collaborate with Global Logistics, Supply Chain, Warehouse Operations, Customer Service, Regulatory, and other cross-functional groups to ensure compliant product distribution.
- Provide QA input into operational improvements, issue resolution, and process standardization.
Requirements:
- Bachelor’s degree and 4+ years of relevant experience OR
- Master’s degree and 2+ years of relevant experience
Benefits (if eligible, as stated):
- Discretionary annual bonus and discretionary stock-based long-term incentives (eligibility may vary)
- Paid time off
- Company-sponsored medical, dental, vision, and life insurance plans
Application Instructions:
- Apply via the Internal Career Opportunities portal in Workday.
Responsibilities:
- Review and approve deviations, investigations, and CAPA records associated with Global Logistics activities.
- Support change controls related to distribution processes, transportation lanes, and 3PL operational activities.
- Conduct quality reviews of distribution and operational documentation (e.g., shipping records, environmental monitoring, temperature excursions).
- Partner with QA colleagues to ensure compliance with GDP, GMP, and applicable regulatory requirements.
- Provide QA oversight of global 3PL partners, including assessment of operational compliance, quality performance, and adherence to Gilead standards.
- Monitor and review logistics data to identify quality trends or potential process improvements.
- Contribute to routine quality metrics reporting and partner with Logistics to address identified gaps.
- Participate in development, revision, and maintenance of SOPs related to distribution and logistics operations.
- Support internal audits and external inspections pertaining to distribution activities.
- Ensure consistent application of quality policies, procedures, and industry best practices across the logistics network.
- Collaborate with Global Logistics, Supply Chain, Warehouse Operations, Customer Service, Regulatory, and other cross-functional groups to ensure compliant product distribution.
- Provide QA input into operational improvements, issue resolution, and process standardization.
Requirements:
- Bachelor’s degree and 4+ years of relevant experience OR
- Master’s degree and 2+ years of relevant experience
Benefits (if eligible, as stated):
- Discretionary annual bonus and discretionary stock-based long-term incentives (eligibility may vary)
- Paid time off
- Company-sponsored medical, dental, vision, and life insurance plans
Application Instructions:
- Apply via the Internal Career Opportunities portal in Workday.