BEPC Inc. is seeking tohire two (2) full-time Supplier Quality Auditors who are qualified to executesupplier compliance audits that are in conformity with Current GoodManufacturing practices and Quality System Regulations.
Summary: The Supplier QualityAuditor is a subject matter expert in the field of auditing across the complexand highly regulated manufacturing industries of medical devices,pharmaceutical, biotechnology, microbiology, and sterilization sciences. Musthave a profound understanding of key biophysical characteristics of thousandsof raw materials and all the processes in the manufacturing supply chain, whichincludes understanding each medical devices' unique design, mechanical, andelectrical specifications. This knowledge is critical for ensuring compliancewith the most appropriate packaging, labeling, storage, installation, andservicing of all finished medical devices.
Job Duties: Prepare, plan, scheduleand create timelines for completions of supplier audits. The planning andpreparation phases involve extensive research into the study and analysis ofpast audit results of the supplier being audited. Auditor must draw upon theirtechnical knowledge/expertise and their analysis of the supplier to effectivelyprepare for the audit. Apply scientific knowledge and specified regulations tothe relevant industry being audited to execute medical device manufacturersupplier compliance audits that are in conformity with Current GoodManufacturing Practices, Good Laboratory Practices (GLPs), ISO, Federal DrugAdministration and similar international Quality System Regulations. Dutyincludes leading "for cause" audits of external suppliers. Dutyincludes ensuring the supplier's microbiological testing procedures areperformed properly. These audits are focused on evaluating each supplier'smanufacturing operations, quality control testing, laboratory testingfacilities, and warehouse/distribution facilities to ensure compliance withcustomer and governmental regulations. As part of a thorough and compliantaudit, information collected during the audit must be critically analyzed toidentify systems and process gaps and develop opinions/documenting observationsregarding compliance risk. Prepare, summarize and write technical auditreports, including nonconformance observations, trends, tables, graphs, andslides; issue audit reports; respond to positions set forth by suppliers,develop corrective/preventative action plans; and identify the patterns andtrends of supply quality problems for review by the Supplier Auditing Manager.Review and evaluate supplier's audit responses against current industry andregulatory standards to assure sufficient controls are in place to meetcustomer specifications. Auditor must also ensure suppliers have appropriateCorrective and Preventative Actions (CAPAs) in place for any deviations foundin supplier manufacturing. Provide scientific and/or technical advice tosuppliers and customers in regard to audit results and FDA compliance.Participate in the development of protocols/reports in support of test-methodvalidations, design and process verifications and validations,biocompatibility, sterilization, shelf life, stability, and risk management.Auditor must also author and revise technical documents and procedures relevantto the auditing function. Conduct technical training. Auditor must also act asrepresentative of BEPC when presenting audit reports to clientele, whichincludes preparation and presentation of presentations, verbal and audiovisualand holding meetings. Close audit after assessments and reports are finalized. Defendsupplier practices during regulatory agency audits.
MINIMUMREQUIREMENTS: Qualified candidates must have a bachelor's degree in Engineering,Life Sciences or related field and 36 months of experience in qualityengineering or quality systems auditing. Qualified candidates must also have certification as an auditor, such as ASQ, biomedical, regulatory affairs and/orISO quality management.
TRAVEL REQUIREMENTS: Position may workfrom anywhere in the United States remotely because position largely involvesconducting desktop audits of supplier manufacturers who are located in theUnited States and globally. Position also requires frequent travel to visitsuppliers to conduct on-site regulatory compliance audits.
