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Job #03034

About our client Our client is a privately held medical device manufacturer with operations in over 28 countries. With marketed products, an experienced management team, and an empowering corporate culture focused on the professional and personal development of its employees, it is a great opportunity for the right candidate. Position Location Senior Quality Assurance Manager Pennsylvania Salary Highly competitive package, commensurate with experience Responsibilities 1) Manage all support investigations for incident reports for manufacturing, QC/Micro out-of-specification and out-of-trend test results 2) Handle all facility reports and calibration out-of-tolerance notifications 3) Oversee environmental monitoring action reports 4) Handle non-conforming material reports and batch failure investigations 5) Propose and approve CAPAs 6) Investigate and respond to product complaints 7) Participate (proactively) and direct batch failure investigations 8) Review and approve all SOPs, engineering/software change requests, validation protocols/reports and engineering drawings 9) Perform and monitor the inspection of products for accuracy and quality 10) Assist with the review of documents and data submitted in support of regulatory submissions 11) Maintain QA control of raw material reserve samples Requirements 1) BS in Chemistry 2) 10 years of relevant pharmaceutical industry experience 3) Experience in decision processes, problem-solving, root cause analysis and constructive issue resolution 4) Previous experience in managing overseas staff in India 5) In-depth knowledge of cGMPs, EMEA and MHRA regulations and their application 6) Understanding of performing regulatory agencies’ general audits 7) Ability to work successfully in a fast-paced, rapidly changing environment