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Quality Assurance Senior Specialist
West Greenwich, RIDescription:
Note:
Responsibilities:
Basic Qualifications
Top 3 Must Have Skill Sets:
Primary:
Nice to haves:
Pay Rate- between $35 - $40/Hr on W2 based on experience.
"This posting is for Contingent Worker, not an FTE"
Note:
Responsibilities:
- Primary focus is the support and oversight of Amgen’s Quality Management Systems ensuring key requirements and initiatives are implemented, maintained and reviewed in accordance with cGMP regulations. Additional detail responsibilities, accountabilities or decision authorities are defined in procedures to execute assigned task for the role and deployed through assignment of procedure training in the Learning Management System. Responsibilities could include:
- May be responsible for leading and directing the Quality functions for assigned plant(s) or functional area(s)
- Responsible for providing Quality oversight to ensure that Amgen’s systems are executed, according to current Good Manufacturing Practices (cGMP) and other applicable regulations
- Ensures that Quality Management Systems comply with cGMP practices and other applicable regulations
- Provide support for Global Process Owners executing key quality systems processes
- Ensures the Quality unit provides review, approval and tracking of cGMP processes, procedures, assays, documents and records, including non conformances, CAPAs, change control records and validations. May execute these tasks
- Supports Continual Improvement initiatives, programs and projects
- Ensures that changes that could potentially impact product quality are assessed according to procedures
- Ensures that deviations from established procedures are investigated and documented per procedures
- Collect and analyze Key Process Indicator (KPI) data to assessing process performance and areas of improvement
- Alerts senior management of significant quality, compliance, supply and safety risks
Basic Qualifications
- Doctorate degree and 2 years of experience OR Master degree and 6 years of experience OR Bachelor degree and 8 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience
Top 3 Must Have Skill Sets:
Primary:
- Quality Management Systems experience (up to and including ownership of a quality system element, implementation of a quality system element)
- Regulatory Compliance experience (up to and including experience presenting to a regulatory authority, ensuring GMP processes are aligned to regulations)
- Ability to coordinate with cross functional teams, ability to communicate up and down management chain
Nice to haves:
- KPI data collection and analysis with presentation to leadership at management reviews
- Strong systems understanding (Microsoft suite, Veeva platform, Trackwise, etc.)
- History of general GMP execution (Deviations, Change Controls, CAPA, Disposition of Product, Regulatory Deviation Reporting, Recalls)
Pay Rate- between $35 - $40/Hr on W2 based on experience.
"This posting is for Contingent Worker, not an FTE"