Quality Systems - Supervisor/Technician/Document Control Specialist
CurrentAs part of this Johnson & Johnson company, I - • Responsible for supervision and mentoring of 4 quality lab technicians of the Complaint Investigations team, within the Quality Department, to accomplish departmental goal objectives. • Reviewed all reported complaints. • Evaluated and approved each investigation report. • Issued requests for credits to Finance department for returned product. • Verified all complaint files fully complied with all regulatory requirements before closing them. • Performed statistical analysis on complaint trending data and created monthly reports for review with the customer quality improvement team.• Prepared reports to communicate key metrics and outcomes of quality activities• Responsible for conducting monthly GMP production audits. Compiled audit results and assigned corrective action reports.• Developed quality assurance policies, and procedures. • Inspected & Audited materials and products, using various scopes, gauges, calibrated equipment & schematics to verify conformance to specifications. • Stored, managed and tracked company documents. • Scan, image, organize and format documents, adhering to the company's records GDP & retention procedures. • Receive and process Requests for Information, Revisions, Creation or Obsoletion of documents from employees and maintain the requests via tracking logs in Microsoft Excel & SharePoint.• Investigated and documented numerous deviation reports, product and process non-conformity reports and CAPA's• Created training system in PowerPoint to train employees on Document Revision, routing and records management procedures and policies, which include documentation, retention, retrieval, destruction and disaster recovery. • Assist with file migrations and audits, and perform administrative tasks as needed.• Maintained a high level of service in accordance with standard operating procedure and all company policies