To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.

Job #03029

About our client Our client is a rapidly growing specialty pharmaceuticals and contract manufacturing company headquartered in Ohio. The organization has been consistently recognized by various publications as a desired place to work and they boast of both an experienced management team and a corporate culture that is focused on the long-term professional development of employees. This is a great opportunity for the right candidate. Position Location Compliance Audit Specialist Ohio Salary Highly competitive package, commensurate with experience Responsibilities 1) Plan and execute compliance audits in support of supplier qualification and internal compliance 2) Determine the degree of compliance of areas/suppliers audited 3) Participate in regulatory Audit Host Team 4) Stay up-to-date on regulatory guidelines and corporate policy to ensure compliance with requirements 5) Work with audited areas/suppliers to identify appropriate corrective and preventive actions (CAPA) 6) Perform CAPA follow up through written confirmation or on-site verification to ensure timely closure of corrective action commitments 7) Provide training (as Lead Auditor) and oversee co-auditors and trainees Requirements 1) BA/BS degree in Life Sciences, Engineering or a related discipline 2) Certified Quality Engineer and/or Certified Quality Auditor (i.e., ISO or ASQ) preferred 3) Minimum 3 years of experience in the pharmaceutical industry, conducting internal (PAI/FDA) and supplier audits (GMP) 4) Experience in conducting internal and/or supplier audits 5) Expertise in validation, process engineering, aseptic manufacturing or analytical chemistry a plus 6) Experience in technical field preferred 7) Working knowledge of standard business software packages (Microsoft preferred) 8) Superb project management skills 9) Excellent interpersonal and written communication skills 10) Sound judgment and good analytical skills to enable assessment of risk 11) Willingness to travel (up to 20%)