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Job Title: QA Auditor
Category:  Architecture (797)
Description:   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.
Requirements:   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
Location  Not specified
Minimum Experience (yrs): 
Required Education:  Not Specified

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