QA Systems (Caliber) Coordinator
Quality, Incorporated
 Somerville, NJ

Description:

The Quality Systems Coordinator leads and reports data generation, data analysis and data interpretation. Create summary findings to support investigations, Corrective and Preventive Action (CAPAs), complaints etc. Monitors short-term and long-term effectiveness checks and monitors quality assurance trends related to Quality Management System (QMS) processes.

Essential Functions:

  • The Quality Systems Coordinator provides coordination and reporting that includes data generation, data analysis, data interpretation. Also, prepares summary findings to support investigations, CAPAs, complaints etc. Monitors short-term and long-term effectiveness checks and monitors quality assurance trends related to Quality Management System(QMS) processes.
  • The QA coordinator will work collaboratively with users of quality system software on the collecting and distribution of reports related with quality documents. This includes coordinating and facilitating all aspects of planning, evaluation and reporting, problem resolution and solution to any quality issue.
  • Performs evaluation of Change Controls in accordance with established procedures and ensures close out of these documents.
  • Provides Quality Assurance(QA)management with timely data analysis and insights for potential corrective actions and improvements; and works collaboratively with QMS process owners, QA management and stakeholders to support quality improvement and data collection and organization.
  • Participates in nonconformance root cause investigations requiring data to support completion of Investigations, complaints and CAPAs.
  • Informs QA management of any activities/decisions that may impact the compliance of the sites that may lead to regulatory action. Prepares and/or ensures of extension memos for investigations determined not able to meet scheduled investigation due dates. Performs risk assessments in Qumas/Caliber respective to investigations for Process deviations, Laboratory OOS documents and Quality Complaints.
  • Weekly audits of the Quality Assurance Systems
  • Evaluate documentation for completeness and consistency, and assign additional actions as necessary to close the document
  • Manages the New Product Launch Checklist from data collection to approval.

Additional Responsibilities:

  • Assists with development of metrics and performs analysis of quantitative and qualitative data to identify developing trends, monitor product quality, assesses QMS process performance and generates weekly, monthly, quarterly and ad hoc reports for QA management review.
  • Assist with internal and regulatory audits as requested.
  • Assist with analyzing, displaying and customizing data reports in formats such dashboards, scorecards, and presentations. Assists in the development of new reports.

Education:

  • High School Diploma or GED 4yrs or more related QA field experience is required.
  • Associate Degree 2yrs or more related QA field experience is preferred.
  • Bachelors Degree (BA/BS) 1yrs or more related QA field experience is preferred.

Experience:

  • 4 years or more experience with a High School 4 yrs or more related QA field experience is required.
  • 2 years or more in AD 2yrs or more related QA field experience
  • 1 year or more in BA/BS 1yrs or more related QA field experience

Skills:

  • Excellent organizational skills with proficiency in MS Word, Excel, and Powerpoint - Advanced
  • Highly flexible and adaptable. Ability to work independently with minimal supervision in a fast paced environment. - Advanced
  • Thorough understanding and familiarity with GMP regulations including 21 CFR 210 and 211, ICH guideline knowledge a Plus - Advanced
  • QA/QM systems software preferably with Quimas and caliber - Advanced

Specialized Knowledge:

  • High energy level and organizational skills.
  • A certain degree of creativity and latitude is required.
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