QA Oversight Associate

The QA Oversight Associate provides support to all functions associated with manufacturing and quality control operations via daily on-the-floor support.   The oversight includes evaluation and review of ongoing Manufacturing and Quality Control Operations, and management of all Quality functions related to facility, systems, and manufacturing support. Other areas include (but are not limited to) Metrology, Engineering, Maintenance, and Information Systems (IS). Essential responsibilities include but are not limited to:

• Ensure that all applicable US and European regulatory requirements are being met within the procedures and practices of the Manufacturing and Quality Control units.
• Conduct daily “audits” of the Manufacturing and QC facilities to ensure that all products produced meet labeling, dating, and packaging requirements as defined by Standard Operating Procedures (SOP’s) and current Good Manufacturing Practices (cGMP).
• Provide necessary daily, weekly and monthly summaries and reviews for on the floor observations, provide responses to observations and ensure that all corrective action measures are completed as described and within the time-frame given in the response.
• Recognize potential problems and/or document problems encountered, following up with department supervisors to assure corrective actions are taken to resolve any deficiencies in product quality or manufacturing systems and procedures.
• Ensure that investigations related to deviations in facility or support systems are complete and adequate.
• Position requires the ability to solve complex problems independently and within a team environment.
• QA oversight of aseptic processing.
• Assist in training of any new QA Oversight personnel.