Claims Quality Audit Manager jobs in Beaumont, TX

In this role, you and your regional colleagues will manage the quality audit program for external suppliers in the APAC region. You will lead or co-lead quality audits to analyze and ensure that the basic processes of our plants and suppliers are effective. You will work with third party audit companies who will perform additional audits. Through the audit outputs, you will evaluate suppliers and our quality systems to ensure full compliance to all applicable regulatory requirements.

Main responsibilities:

·       Perform audits of suppliers – Audit activities include defining the audit objective, defining audit requirements, scheduling audits with suppliers, conducting opening & closing meetings and performing audits as the lead or co-auditor for components, raw material, 3rd party manufacturers, distribution centers, and internal manufacturing sites, and third party testing laboratories

·       Completing and issuing audit deliverables such as audit checklists and audit reports

·       Reviewing and issuing audit reports for audits conducted by third parties

·       Ensure that audits are conducted according to proper policy and requirements, that every audit has a timely audit report issued, and that CAPA plans are identified for every audit.

·       Communicating audit status and audit results to internal stakeholders. Escalating significant issues noted during audits to the relevant organizational leaders.

·       Maintain the audit tracking databases with audit schedule, audit report, and audit observations. Rank suppliers according to risk profile. Participate in collecting and reporting quality matrix.

·       Collaborate in continuous improvement of the audit program.

Requirements/Qualifications:

·       Minimum 5 years experience auditing external suppliers, preferably in the pharmaceutical, medical device, dietary supplement, cosmetics, or food industries.

·       Good knowledge of applicable regulations and guidance documents for cosmetic and OTC products, able to apply critical thinking skills to evaluate requirements.

·       Knowledge of global cGMP standards.

·       Working knowledge of US 21 CFR 210, 211, NMPA Good Manufacturing Practices for Cosmetic Products, Health Canada GMP’s, ISO 22716, EFfCI, and ICH Q7.

·       Excellent Knowledge of Microsoft Office, SAP is a plus

·       Flexibility and willingness to travel up to 60%.

Contract Duration: 1 year, full time hours

Pay Range: $45-$50 USD/hr