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.
  • 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).
  • Minimum two (2) years of experience within the pharmaceutical industry in quality function role.
  • Experience working in an international multicultural matrix organization.

Meet Your Recruiter

Apply Online

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.

About New Brunswick, NJ

Ready to take the next step in your career? Explore job opportunities in the vibrant area surrounding New Brunswick, New Jersey! Known for its bustling job market and dynamic growth opportunities, this region is a hotbed for talent looking to thrive in a diverse and exciting professional environment. Home to renowned landmarks like the Rutgers University campus and the historic State Theatre, as well as a rich culinary scene offering a taste of authentic New Jersey cuisine, there is no shortage of charm and culture to discover here. From the lively atmosphere of George Street Playhouse to cheering on the Somerset Patriots baseball team at TD Bank Ballpark, New Brunswick and its surrounding areas offer a unique blend of opportunities for career growth and personal enrichment. Dive into our job listings today and unlock your potential in this captivating region!