QAO Specialist I

B.A. or B.S. degree preferably in scientific or technical field (e.g., chemistry, biology, physics, engineering, computer science, technical writing)
0-2 years’ experience working in a cGMP regulated environment such as the field of quality, manufacturing or engineering field, applying the cGMP rules in everyday activities
Proficiency in Microsoft Office
Proficiency in QA systems preferred

Responsible for assisting with investigating deviations relevant to area of responsibility. Responsible for participating in investigation meetings with responsible department and any required support groups.
Responsible for participating in necessary research to determine root cause, corrective/preventative actions, product disposition, and using the investigation tools provided by QAO Management.
Collaborate with manufacturing personnel to perform root cause analysis at time deviation occurs and assist in determining robust corrective/preventive actions.
On-call for immediate inspections, investigations, and review of possible GMP related issues and ability to provide quality assessment of potential deviation.
Responsible for real-time review of critical in-process steps (e.g. viral reduction / sterility assurance), review/approval of completed production records, and providing immediate notification to manufacturing personnel (e.g. supervisors/operators) regarding facility/process /equipment /documentation issues.
Execute training/awareness related to investigation and GMP changes to production personnel.
Drive continuous improvement on production floor to ensure compliance to cGMPs.
As appropriate to area of responsibility, responsible for ensuring sample retain area is maintained in a state of compliance and all annual inspections are completed in a timely manner.
As appropriate to area of responsibility, perform Acceptable Quality Level (AQL) assessments.