|| Perform audits, including focused and general audits of Operations, Distribution, Label Production, Facilities and Quality Assurance areas against cGMP standards and ensures resolution of any identified issues. Visit and audit identified material and component vendors to obtain information related to supply quality, capacity of vendor to meet orders and vendor quality standards. Review and update Quality Agreements as appropriate. Investigate deviations, discrepancies, technical problems, procedures, complaints and non-conformance of materials and processes. Prepare detailed written report of investigations and audits with recommendations for corrective and preventative actions to problems and changes to procedures to ensure high quality is the company standard. Schedule and coordinate audits with outside vendors which conduct supplier certification, inspection or other quality related reviews. Participate actively in meetings and shares pertinent updates and other developmental activities. Adhere to set safety standards. Participate actively in regular meetings. Achieve expected performance measures. Other duties as assigned.
|| Bachelors’ Degree or equivalent in science related field. 5 – 7 years in pharmaceutical or biotech manufacturing in a Quality or Compliance role. 2 – 3 years as QA Auditor in pharmaceutical or biotech manufacturing. Demonstrated ability to work independently, handle multiple tasks simultaneously and negotiate and meet critical timelines. Excellent oral and written communication is required to communicate with the team, peers, management and external contacts. Ability to interpret FDA & DEA Regulations and assure compliance with cGMPs, . Strong working knowledge of personal computers and Microsoft Office Products, including Word, Project and Excel. Ability to travel up to 30%, domestic and international