Quality System Associate
Oakland-Fremont-Pleasanton Metro Area, CA
- Create, review and approve non-conformance QAR for audit observation, equipment non-conformance, unplanned deviation, out of specification, non-conformance exclusion and validation deviation.
- Review and approve change request, affected document reviews and implementation activities for document and process changes.
- Equipment installation/operational qualification review and approval.
- Collaborate with key stakeholders to identify and implement compliant solutions.
- Work with CAPA management, as required.
- Supports management of Internal and External Audits/Inspections (e.g., backroom support, scribe, coordinate inspection readiness activities, manage non-conformances, etc.) Communicate product quality and compliance-related issues to Manager as needed.
- Expected to operate independently, holding him/herself accountable to proactively fulfill tasks and achieve results within assigned timelines.
Strong communication skills (oral and written) with the ability to present at functional level.
Demonstrated competencies in team member participation.
Able to use Trackwise and other tools in conjunction with non-conformance management.
Education Bachelor s degree in relevant technical field (Chemistry, Biochemistry, Molecular Biology, Engineering or related scientific discipline