Supplier Quality Contractor
2 months ago
Pay Rate: $55.00/hour$73.00/hour DOE
Hours: 8:00 a.m. to 5:00 p.m.
Location: Onsite in South San Francisco, CA
Duration: 1 year
Provide quality and compliance oversight for external GxP suppliers, including CMO, CLO, suppliers or distributors of direct materials or critical process-contacting spare parts, suppliers for analytical equipment or manufacturing systems, and service providers to ensure compliance with cGMP and Quality Agreement requirements
Manage designated suppliers and participate as part of GxP supplier cross-functional management teams to enable (as applicable for the supplier lifecycle stage) site selection and implementation (including due diligence activities), ongoing quality supply of commercial products, materials or services from suppliers, and decommissioning.
Technical Job Responsibilities
Support External Quality GxP Supplier Quality Managers in the following activities associated with their role:
Oversee all required quality activities during the lifecycle of a GxP supplier (Source & Select, Implement, Manage, and Decommission), including but not limited to: process or method validations, Client and Health Authority audits, complex investigations, market complaints, and regulatory submissions
Develop, negotiate and maintain risk-based Quality Agreements and Product Specific Requirements (as appropriate) with GxP suppliers and ensure compliance with agreements.
Collaborate with GxP suppliers to address gaps of audit responsiveness, CAPA implementation, deviation reporting and management, complaint management, investigation closure, and change implementation with regard to quality and time with the supplier; and escalate as appropriate
As applicable, support or lead supplier improvement initiatives to solve complex manufacturing or quality problems. Identify, design and implement process and system improvements. This includes support for implementation of or changes to enterprise-wide systems, such as SAP, Veeva and MDMS/GLAS.
Qualifications and Skills
B.A. or B.S. degree in life sciences or equivalent
Previous experience in the pharmaceutical or related industry or an equivalent combination of education and experience is a plus
Ability to interpret quality standards as they relate to GxP suppliers
Operational Excellence expertise is a plus
Highly competent in MS Office or Google Suite applications including Excel, PowerPoint, Word, and MS Project, etc.
Ability to communicate clearly and professionally both in writing and verbally
Benefits:
•Health insurance
•Health savings account
•Dental insurance
•Vision insurance
•Flexible spending accounts
•Life insurance
•Retirement plan
All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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