Quality Assurance Coordinator

ESSENTIAL DUTIES and RESPONSIBILITIES :

• Approve batches for release
• Inspect production records (batch records, bar code labels, inspection sheets) and visually confirm a sample for each finished good.
• Ensure compliance with all established procedures and quality requirements, investigate and resolve discrepancies.
• 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 items fromher response formance of designated Quality Assurance process activities :
• 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.

MINIMUM QUALIFICATIONS :

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.

Benefits :