Quality Systems

4 weeks ago


Newark, United States Careerbuilder-US Full time

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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