The Quality Auditor – Suppliers will have responsibility for supplier audit planning, scheduling, execution, documentation, reporting and follow up.
The Quality Auditor – Suppliers will have responsibility for supplier audit planning, scheduling, execution, documentation, reporting and follow up. The auditor must maintain relevant knowledge regarding regulatory expectations around supplier management, and ensure the local supplier auditing program reflects these requirements. The auditor must report on supplier risk, audit status, and follow up on audit commitments. The supplier auditor must be a self-starter and have excellent written and verbal communication skills, time management skills, and must be able to communicate with external and internal customers at various levels within the organization. The auditor may also support internal and global audit activities as needed.
Schedule and conduct, with other QA support as necessary, supplier audits to meet current regulatory and Global Quality expectations. Will require some domestic and international travel.
Develop and maintain supplier audit schedule. Schedule to be developed based on supplier risk and prior audit history. Prepare risk assessments as necessary for suppliers who do not allow audits.
Develop supplier audit reports, follow up on supplier commitments.
Report on audit status, supplier issues to management, including the highlighting of areas/suppliers that require further action to be taken.
Manage travel budget to support audit requirements
Education: BS in Scientific discipline
ISO Lead Auditor 13485 or 9001 or CQA
Experience: 5 – 8 years of Quality Auditing or Compliance experience in a pharmaceutical/medical device industry. Need to demonstrate strong understanding of Pharmaceutical GMPs and Quality System Regulations and current industry practice, with emphasis in pharmaceutical / medical device manufacturing. Experience in sterile drug products manufacturing preferred. Strong knowledge of supplier selection, evaluation and auditing programs in the pharma industry preferred. Experience with ISO 13485 and ISO 9001:2001 required.
Preferred Skills: Strong organizational and communication skills required in order to develop programs, work independently with minimal supervision and effectively interact with all levels of the organization, including suppliers. Excellent time management skills. Demonstrated technical writing and proficiency with Excel and Microsoft Word.