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The Internal Auditor, Regulatory Compliance will have an in-depth understanding and knowledge of appropriate GMP compliance and other applicable national and international regulations, laws, and lntegra LifeSciences procedures and processes, which allows for planning and conducting of internal audits. Internal Auditor must be detail oriented, able to maintain a 'big picture' / overview on the project / business, exhibit a high degree of flexibility and initiative, demonstrate the ability to follow up on multiple tasks and projects, and possess the ability to handle confidential information diplomatically. As liaison with Management and staff, provide direction and coordination for project activities related to assigned areas. 

ESSENTIAL DUTIES AND RESPONSIBILITIES 

• Proactively provide input to management on audit plans / strategy. Maintain annual internal audit schedule. 

• Coordinate, conduct (as lead or contributing auditor), and provide follow-up for internal audits and/or assessments of all GMP/GLP related site activities. 

• Assembly and coordination of the audit team, preparation of the audit plan, leading audits, writing audit reports and Audit Nonconformance Management. 

• Review and approve, in collaboration with the responsible quality units, proposed corrective / preventative action plans. Verify implementation and effectiveness of CAPAs. 

• Identify areas for process / procedural improvements, providing input to management and taking the initiative, as appropriate. 

• Participate in continuous improvement project teams, determine effectiveness of improvement activities and applicability to other divisions, and provide on-going project support and governance, as assigned. 

• Provide support for regulatory inspections, input to responses and corrective action plans and ensure the completeness and appropriateness of commitments. 

• Provide training on audit, compliance and inspection techniques to related departments/personnel. 

• Contribute to team objectives as assigned. 

• Mentor and assist with training of less experienced auditors. 

• Participation in vendor change notification assessments. 

• Participation in review of supplier quality agreements, as needed. 

• May also perform other related duties, responsibilities, and special projects as assigned. 

DESIRED MINIMUM QUALIFICATIONS / EDUCATION REQUIREMENTS 

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position. 

• Bachelor's degree in chemistry, Biology, Pharmacy, Engineering or related scientific discipline. 

• Broad business awareness. Expertise in one or more of the following areas: 

• Manufacturing of medical devices, pharmaceutical API, or drug products, Facilities,  Engineering, Laboratories, or Microbiology. 

• Excellent leadership, facilitation and organizational skills. 

• Strong knowledge of auditing techniques. 

• Minimum of 3-5 years of Medical Device, Pharmaceutical or related experience, preferably in FDA regulated industry. 

• Experience with the application of FDA and/or ISO Quality System Requirements. 

• Evidence of a strong work ethic, demonstrated leadership, and an ability to quickly and effectively learn new skills is required. 

• Demonstrated working knowledge of cGMP and applicable regulatory requirements. 

• Strong technical writing and oral communication skills.