IPQA Associate - Weekend Evening Shift

Ascent invests a tremendous amount of time and money to ensure that we provide value to our client and industry relationships. Our CEO often tells clients that before they select a vendor they should leverage the knowledge of their peers at other companies in the industry.

• The Manufacturing In-Process Quality Assurance Associate (IPQA) will focus on initial deviation investigative phases related to manufacturing process deviation.
• Specific responsibilities will be responding to manufacturing calls for assistance, documentation and immediate corrective action associated with these deviations.
• IPQA associates are responsible for responding to customer needs immediately, ensuring appropriate corrective action is taken and process controls are in place.
• IPQA associates work closely with Quality Engineers and QA Management to ensure thorough and complete investigation activities.
• The IPQA Associate is responsible for the receipt, documentation, evaluation, follow-up and investigation of all technical product complaints for drug products.
• Carries out all responsibilities in accordance with policies and procedures as well as state, local and federal laws.

• Responsible for identifying deviations in the processes that ensure all activities are cGMP compliant, identifying corrective actions, establishing path forward activities, and appropriate documentation is complete.
• Facilitates use of existing management processes regarding deviations, investigations, and preventative actions.
• Ensure compliance with SOPs, Policies and Procedures as required by Sandoz and regulatory agencies
• Performs area assessments and ensures compliance in all activities with cGMPs and Compliance activities
• Identifies deviations in processes and initiates corrective actions
• Administration and management of deviations/investigation/Client systems in Trackwise
• Control materials for compliance purposes in SAP
• Actively involved with Investigation Review Board. Individuals will be required to maintain responsibility for management of specific process
• May be asked to perform QA sampling duties as required
• Maintains active communication with customers to facilitate continuous process improvement.
• Other duties as assigned.

• BS or BA degree in Chemistry, Science or Engineering field
• 2 - 4 years of experience with BS, 0 - 2 years of experience with MS
• Minimum of 2 years in QA
• cGMP experience required.
• Trackwise /SAP experience
• Pharmaceutical and Manufacturing experience
• Packaging Line Clearance Experience a plus