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Pinpoint Pharma

Quality Systems Analyst

Post Date:May 17, 2018Type:Full-Time
Start Date:5/17/2018Salary:$60,000.00
Location:US-IL-Vernon Hills Job Reference:
Skills:

Requirements:

  • Bachelor’s degree required, preferably in Healthcare, Biology, Quality, or Engineering.
  • Minimum two years in a regulated industry in a quality systems/assurance role.
  • Highly organized and systematic, superb attention to detail and ability to complete tasks with a high degree of accuracy.
  • High degree of project management skills and can multi-task without direct supervision.
  • Effective written and verbal communication skills.
  • Proficiency is required with MS Word, Excel, Access and Power Point. Sharepoint experience is a plus.
  • Knowledge of applicable regulatory requirements for clinical trials such as ICH/GCP E6.


Job Description:

Job Title:  Quality System Specialist

Salary:  $50,000 - $60,000

Job Overview:  The Quality System Specialist position is available for an experienced individual to provide assistance to the Associate Director, Quality Systems to ensure the company is in compliance with regulatory requirements and established procedures.

  • Performs all manners of document control activities (review, track, maintain, and archive) in accordance with established policies.
  • Assist in managing the internal training program and personnel documentation.
  • Assist in the evaluation activities of current and potential vendors.
  • Support audits of internal systems as needed.
  • Participate in external inspections.
  • Assists in the gathering, trending and reporting of metrics that measure and communicate quality performance.
  • Applies creative and innovative approaches to maintain a high level of effectiveness, efficiency and productivity in Quality Systems operations within assigned area of responsibility.
  • Fosters a climate of teamwork to work across the Quality Systems Department, other departments, vendor partners, and Customers to achieve synergy, effectiveness and efficiency.
  • Enhances the effectiveness of the department by developing and maintaining automation, procedures, systems and reporting methodologies.
  • Performs other related duties as assigned.

Key Skills:  Quality Systems, Audits, Vendors, Regulatory, Compliance, Metrics, Suppliers, ICH, GCP, Microsoft, Clinical, SOP's, Healthcare





Contact Information
Pinpoint Pharma
Name: Lisa Mazur
Ph: (847) 574-7274


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