Quality Operations Manager

Essential Functions and Responsibilities

• Lead the Quality Operations team, ensuring daily support for all manufacturing 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 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.
• Final product release.
• Issuance of batch records and labels.
• Assist with investigation of manufacturing deviations, OOS results, temperature excursions and other non-conformances.
• 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.
• Initiate and participate in standard operating procedure (SOP) revisions to improve Maintain and report on Quality Metrics.

Required Education, Skills, and Knowledge

• A Bachelor s Degree in Science, Engineering, or a related technical discipline
• At least 8 years of experience in the pharmaceutical industry in an aseptic manufacturing environment.
• Knowledge of cGMP regulations.
• Skilled in use of Microsoft Word, Excel, and PowerPoint.
• Familiarity with QMS systems.