Quality Assurance/Regulatory affairs Specialist

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ConfidenceUSA
138 Haven Aveue
Port Washington, NY
Posted: February 09 2016
Application Deadline: Available Year-round
Position: Full-time, Paid

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Description

Duties 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

Certification Requirement:
Bachelor degree or above in QA/QC and Regulatory affairs, or relevant degrees.

Other Requirements:

Must: Billingual in English and Chinese
Optional: HPLC, TLC, GC, UV-Vis, Titrimetric method, Dissolution test, ERP (JD Edwards), SPSS, etc.

How To Apply

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