Job Title:

QA Systems Specialist II

Department:

Quality Assurance

Reports to:

Quality Assurance Manager

EEO Category:

Professionals

FLSA Status:

Exempt

Position Summary

The QA Systems Specialist II is responsible for assisting in the management and administration of the Quality Management System (QMS) and its associated activities. In order to improve operational efficiency regulatory compliance with cGMP and regulatory requirements and to meet operational needs, the QA Systems Specialist I may assist in the management of other electronic software/systems on behalf of of the department.

Duties and Responsibilities

• Assist in the administration of the QMS Software, including user management, analytics/reporting, system maintenance and other administrative duties as required, in support of clinical, commercial and development activities
• Assist in the administration of the Electronic Logbook System, including user management, system maintenance and other administrative duties as required.
• Assist in the administration of other managed system(s), such as LIMS, SAP or Equipment Management software, as assigned
• Implement modifications to managed system(s) in adherence with change management procedures at SSM, as assigned by area manager
• Assist in guiding users through proper use of, or creating training materials for, managed system(s)
• Communicate with vendors and technical support to coordinate and address technical issues in managed system(s)
• Ensure applicable regulatory requirements are applied in managed system(s) and work is performed within those requirements

• Exhibit a quality mindset and a drive to learn and develop within this role

• Other duties as assigned

Regulatory Responsibilities

• Gain an understanding of FDA, EU, and other regulatory agency requirements, in support of the duties and responsibilities listed above

Supervisory Responsibilities

• N/A

Experience

• Two (2) to four (4) years of work experience in an office environment, preferably in a related field, or a combination of education and related work experience
• Recent experience in the pharmaceutical industry or a quality assurance role is preferred

Education

• Minimum of High School Diploma
• Associates degree preferred

Knowledge, Skills & Abilities

• Comfortable and motivated to learn, use, and evaluate new software/systems
• Experience using MS Office Application (Specifically Word and Excel)
• Strong attention to detail with regard to data entry/review
• Strong written and oral communication skills
• Ability to prioritize well, and shift between tasks as business needs arise
• Good customer service skills
• Ability to manage timelines to meet assigned goals
• Self-motivated and able to work independently without continuous direction
• Working knowledge of JavaScript, VBa or SQL a plus, but not required

Physical Requirements

• Ability to sit for prolonged periods of time
• Long periods of computer screen time
• Ability to lift up to 10lbs

I am aware of the relevance and importance of my activities and how they contribute to the achievement of Sharp Sterile Manufacturing's Mission, Vision and Value.

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Manager

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