Specialist, Quality Systems II

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Job description

Title: Quality Systems Specialist, II

Location: San Diego, CA (Hybrid)

Duration: 12 Months

Job Description:

Responsible for assisting in the development, implementation and maintenance of the quality management systems(QMS) program.

This includes assisting with the oversight of eQMS records (including Change Management, Deviations and CAPAs) and their timely completions.

Primary Responsibilities:

" Provides support for the implementation and maintenance of the quality systems program

" Assists with the oversight of the Corrective and Preventive Action (CAPA) process to ensure CAPAs and associated records are reviewed, and completed in a timely and compliant manner.

" Assists with the oversight of the Change Management program to ensure continuous compliance of the Quality System. Assist with ensuring timely completion/closure of change control records.

" Assists with the oversight of the Deviation process to ensure deviations and associated records are reviewed, and completed in a timely and compliant manner.

" Management of electronic Quality Management System (QMS) (e.g., Veeva Vault QMS), including troubleshooting issues through testing in Veeva Sandbox environment.

" Review and execution of PQ scripts within Veeva Test environment.

" Ensures quality systems procedures, systems and processes are effective and meet regulatory requirements and business needs.

" Provides support for internal audit and regulatory inspections of quality management systems.

" Other duties as assigned/required.

Education/Experience/Skills:

Bachelor's degree in Life Sciences or an equivalent combination of relevant education and applicable job experience may be considered.

A minimum of 3 years Quality Systems experience.

" Proficiency in Microsoft Excel, Word, and Outlook.

" Critical thinking skills in analyzing and exercising judgement on complex issues, guided by a thorough understanding of quality philosophy.

" Strong focus on flexibility, ability to multi-task, attention to detail, excellent organizational skills, good follow-up and judgment and ability to prioritize.

" Skilled at effectively communicating department or area issues and results within and across functional areas.

" Able to gain cooperation of others.Education:

Bachelor's degree in Life Sciences or an equivalent combination of relevant education and applicable job experience may be considered. A minimum of 3 years Quality Systems experience.

Required Skills :

CHANGE MANAGEMENT

INTERNAL AUDIT

MAINTENANCE

MICROSOFT EXCEL

INSPECTIONS

Additional

LIFE SCIENCES

CHANGE CONTROL

QMS

CORRECTIVE AND PREVENTIVE ACTION

Minimum Degree Required: Bachelor's Degree

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