Quality Operations Specialist II - R&D Partners

Essential Functions and Responsibilities

• Helps to ensure compliance to cGMPs and facility procedures. Interface with functional groups, such as Manufacturing, Quality Control, and Document Control, to determine events (errors, deficiencies, discrepancies, deviations and other observations) and report to management.
• Review batch records and related production documentation, ensuring resolution of all identified issues prior product disposition. Work with internal functions to address all identified issues in a timely manner. Reports errors, deficiencies, discrepancies and observations to management.
• Disposition incoming raw materials
• Apply quality compliance theories and principles to independently address a variety of issues of moderate scope. Provide guidance on controlled documents (content, quality, and document lifecycle), identifying gaps, addressing documentation needs, and suggesting process improvements

Basic Qualifications

• A Bachelor s Degree in Science, Engineering, or a related technical discipline or equivalent industry experience.
• At least : 3+ years experience in a regulated industry.
• Working knowledge of cGMP regulations.
• Prior experience and ability to work in an aseptic processing environment.