IPQA Associate I

New Brunswick, NJ

Posted: 05/13/2024 Industry: Scientific Job Number: 24-00213

Job Description

IPQA Associate I
The IPQA Associate I is responsible for identifying deviations in the processes and ensure that all activities are cGMP compliant, identifying corrective actions, establishing path forward activities, and appropriate documentation.

Job Description:
  • Focuses on initial deviation investigative phases related to manufacturing process deviation.
  • Responds to customer calls for assistance, documentation and immediate corrective action associated with deviations.
  • Facilitates the use of existing management processes regarding deviations, investigations, and preventive actions.
  • Performs area assessments and ensures compliance with SOPs, Policies and Procedures.
  • Leverage on-the-floor presence to proactively identify opportunities and provide coaching.
  • Responsible for responding to customer needs immediately, ensuring appropriate corrective action is taken and process controls are in place.
  • Work closely with Quality Engineers and QA Management to ensure thorough and complete investigation activities.
  • Administration and management of deviations/investigation/Client systems in Trackwise.
  • Control materials for compliance purposes in SAP.
  • Execute the final release inspection of packaging lines.
  • Perform acceptance sample analysis for validation and investigation support.
  • Responsible for the review and approval of controlled documents including manufacturing and packaging batch records.
  • Actively communicate with customers to facilitate continuous process improvement.
  • May complete specific project work such as process improvement/remediation, maintain ownership and responsibility for specific QA processes.

Education and Experience
  • Minimum of Bachelor s degree.
  • Understanding of GMPs.
  • Expertise in software applications such as: MS Word, MS Excel, MS Office, Windows, PowerPoint, Microsoft Outlook, Acrobat Reader, TrackWise or similar QMS, LMS (Learning Management System) etc.
  • Knowledge of project management principles, practices, techniques and tools.
  • Strong interpersonal and communication, both written and verbal, skills.
  • Strong organizational and time management skills;must be a ble to prioritize and manage multiple assignments simultaneously.
  • A self-starter with a hands-on approach and a can-do attitude.
  • Minimum two (2) years of experience within the pharmaceutical industry in quality function role.
  • Experience working in an international multicultural matrix organization.

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