Quality Assurance Coordinator en GC America Inc

Description

Summary: Coordinate the cross-functional management and execution of required activities within designated area(s) of the Quality Management System (QMS).

• Approve batches for release:

             o Inspect production records (batch records, bar code labels, inspection sheets) and visually confirm a sample for each              finished good.

             o Ensure compliance with all established procedures and quality requirements, investigate and resolve discrepancies.

             o Track non-standard batch numbers (e.g., multiple batch pairings and/or kit component updates) to assure conformance  with batch pairing and/or kit component procedures.

• Support the document control process throughout the different cycle. 
• Drive the execution of daily management for related QMS processes, taking required action to investigate trouble reports and implement improvements.
• Support the assignment and verification of trouble reports to responsible associates based on issues occurring within related QMS process.
• Support process trouble / CAPA investigations activities, as needed.
• Support the nonconformity process activities, as needed.
• Support the complaint process activities, as needed.
• Prepare standard reports and KPI data and submit to peers and/or superiors according to planned arrangements.
• Prepare and submit data and related evidence for QMS Management Reviews.
• Participate in external audits (ISO, FDA, etc) as a subject matter expert for related QMS processes, as needed.
• Manage the response to audit non-conformities for related QMS processes, as needed.
• Provide Quality Management System training to operations and other departments, as needed.
• Participate in GQM improvement activities including high priority KI projects, as needed.

Requirements

MINIMUM QUALIFICATIONS:

· 3+ years of experience in a regulated industry (Med Device, Food, Drug, etc)

· Demonstrated understanding of Quality Management System requirements (ISO, FDA, GMP, etc)

· Working knowledge and understanding in the use of standard work / SOPs.

· Skills with QC tools & techniques is preferred but not required (Control Charts, Histograms, Pareto diagrams, Cause & Effect diagrams, Process Flow Diagrams, Check sheets, Scatter Diagrams, etc.)

· The ability to communicate with peers in operations to share information, hold nonconforming items, engage on problem-solving activities.

· Experienced in technical report writing and analytical skills

· Skilled in Microsoft 365 tools and technology

Education: BA/BS Degree in science, engineering or related field is preferred. Equivalent experience in Quality related or adjacent role will be considered.

Experience and/or Training: 3+ years of related Quality Management System experience. Quality certification (ASQ, etc.) is a plus.