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

Job #02816

About our client Our client is a world-leading healthcare company that has developed a reputation for successfully bringing impacting products to market in a variety of therapeutic areas. The company has strong financials, an experienced management team and a loyal customer base. They have developed an industry-wide reputation for a positive work environment that ensures employees are up-to-date on current trends and best practices. This is a strong opportunity for someone that wants to put their drive and initiative to work! Position Location Senior Quality Assurance Auditor Melville, New York Salary Highly competitive package, commensurate with experience Responsibilities 1) Prepare and conduct QA and QC audits of contract manufacturer’s issuance of reports to the management 2) Oversee the corrective action process for identified deficiencies 3) Research applicable FDA regulations, EU regulations, TGA, ISO and ASTM standards 4) Ensure (ongoing) compliance with recent changes 5) Create audit schedules for all audits 6) Communicate with auditors and the ones being audited 7) Ensure that audits are conducted within the established timeframe Requirements 1) BS in Pharmaceutical Sciences, Chemistry or a related field (MS preferred) 2) 7+ years of experience in QA and QC 3) Quality Auditor certification from ASQ, RAPS, ISO or an equivalent organization 4) Experience in conducting audits on a national as well as international level of distribution and manufacturing facilities 5) In-depth knowledge of FDA and EU standards, cGMPs, TGA, ISO as well as ASTM standards 6) Expertise in using computers (MS Word, Excel, Access and flow charts) 7) Ability to analyze problems and develop solutions 8) Ability to work independently 9) Excellent leadership skills 10) Keen attention to detail 11) Superb communication skills