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Quality Systems
4 weeks ago
Job Title: Quality Systems & Compliance Specialist
Location: Newark, CA
Duration: 6 Months (Possible extension)
Pay Rate: $83.33/hour on W2
Job Description:
In support of ***'s Quality Systems and Compliance initiatives, Service Provider shall perform the Services identified below and deliver to *** the Deliverables identified below.
Services: This Product of this contract covers the role of Quality Assurance Specialist at the Newark Facility, to support compliance of all applicable computerized systems.
• Assist Quality Systems and Compliance Team in project work for assigned computer systems assessment, implementation and enhancement projects and system rollout.
• Serve as QA Lead on systems implementation projects, quality records, and steady state activities.
• Provide support to ensure system qualification/validation activities are planned, executed, and finalized in compliance with regulatory requirements and ***’s policies and SOPs.
• Support Data Integrity program by serving as QA Lead on gap assessments, risk assessments and remediation plans.
• Develop SOPs, review and approve Validation strategy, plans, protocols, procedures.
• Attend project meetings and workshops.
• Assure system artifacts are in accordance with *** policies, standards, SOPs and meet regulatory standards.
• Serve as QA SME under the supervision of the assigned *** QSC Leadership.
• Perform duties as assigned by *** QSC Leadership.
• Assist in the maintenance of the site-based computerized systems.
• Assist in the assessment, review, and approval of change controls, deviations, and CAPA’s.
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