Supplier Quality Associate
Marin Metro Area, CA
- Provide support for of one or more areas of the Global Supplier Quality systems, including but not limited to specification review and revision, Supplier Change Notification and Supplier Investigation Support.
- Participate in cross-functional Supplier Quality meetings.
- Support development of Supplier related policies, and continuously evaluate and improve practices and systems to coordinate with validation, documentation, and regulatory systems. Strive toward constant improvement of systems in order to maintain compliance cGMP requirements for work performed.
- Assist in development, implementation, and enforcement of departmental policies and practices.
- Participate in inspection preparation, train employees in focus areas and participate in regulatory inspections.
- Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured by the company and for Supplier related approaches utilized
- Other duties as assigned.
- 2+ years experience in a GMP regulated environment, with exhibited knowledge and proficiency working within quality systems.
- Ability to comprehend technical information related to raw material, process and regulatory expectations
- Proficiency with standard software applications, including MS Word (including track changes), MS Excel, MS Powerpoint.
- Understanding and familiarity with FDA, European guidelines Experience and proficient organizational, spelling, grammar and typing skills.
- Effective leadership and communication skills.
- Experience with TrackWise preferred.
- Change Control Experience preferred.
- Experience with Veeva Vault preferred. \
- Regulatory understanding of additional countries such as HPRA, PMDA
- Experience working with international project teams preferred.
- BA or BS in a technical discipline (physical or biological sciences).