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Quality Assurance/Regulatory affairs SpecialistBookmark This
138 Haven Aveue
Port Washington, NY
Posted: February 09 2016
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DescriptionDuties and Responsibilities:
• Establishing and developing company's SOP system, document control system, product specifications and all other documentation systems required by regulations
• Supervising and coordinating QA, QC and production employees' all activities in all aspects of product development from raw materials to finished products for dietary supplements
• Performing routine training activities and inspections to assure all employees and the entire plant adherence to cGMP.
• Communicating with FDA officials, GMP consultants and law teams
• Reviewing and releasing all product batch records for raw materials, labels, packaging materials and finished products
• Reviewing and closing investigations for customer complains, production discrepancies, and OOS, initialing and implementing CAPA if needed
• Monitor and continuously improve the Quality system by evaluating supporting documentation to ensure compliance to cGMP, Industry standards and other applicable regulations
• Prepare documents for change control, process/coating/cleaning validation and took appropriate actions to correct any deficiencies during the production
• Review production batch record/coating master/PKG master and final released all products labeled and packaged in house as well as released all incoming ingredients, bulks, labeling and packaging materials as needed
• Initiate investigations for customer complains, production discrepancy and OOS
• Performe routine inspections of equipment and facilities to ensure required manufacturing in-process controls are implemented
• Lead case-based teams to investigate production discrepancy when needed
• Supervis technicians and laboratory staff with daily laboratory inspection
Bachelor degree or above in QA/QC and Regulatory affairs, or relevant degrees.
Must: Billingual in English and Chinese
Optional: HPLC, TLC, GC, UV-Vis, Titrimetric method, Dissolution test, ERP (JD Edwards), SPSS, etc.