Direct HireJob Summary: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/PAC 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
•While performing the duties of this job, the employee is regularly required to use hands to handle or feel and talk or hear
•The employee is frequently required to stand, walk, sit, stoop, kneel, crouch, crawl, push, and bendQualifications:
•Minimum of Bachelor’s degree
•Minimum two (2) years of experience within the pharmaceutical industry in quality function role
•Experience working in an international multicultural matrix organization
•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 able to prioritize and manage multiple assignments simultaneously
•A self-starter with a hands-on approach and a can-do attitude
•The requirement for English language proficiency for this job role is Intermediate-B1 (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR)