IPQA Associate I
$62,400–$76,960 year
On-siteAll, Catalunya, Kingdom of Spain
Job Summary
Conduct routine area assessments and perform line clearance authorizations to ensure compliance with cGMP requirements, SOPs, and quality standards during manufacturing and packaging operations. Execute conditional and final release inspections, monitor in-process quality checks, and perform retain sample inspections while supporting stability sample collection and AQL verification. Collaborate with Production and Packaging teams to resolve quality issues, review and approve batch records, and manage material status transactions within SAP and TrackWise. Support closure of immediate actions, review validation protocols, and assist with quality improvement initiatives across multiple New Jersey facilities.
Required Qualifications
- Bachelor's degree in a science related major
- Minimum 2 years of experience in a pharmaceutical quality role
- Experience supporting manufacturing, packaging, quality assurance, or quality systems activities in a regulated environment
- Understanding of cGMP regulations and pharmaceutical quality systems
- Experience with electronic quality systems such as TrackWise or similar QMS platforms
- Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, and Outlook
- Ability to review and interpret validation documentation and manufacturing records
- English language proficiency at CEFR Intermediate B1+ level
- Ability to stand, walk, sit, bend, stoop, kneel, crouch, crawl, and reach throughout the workday
- Ability to lift and carry up to 25 pounds
- Ability to navigate office, laboratory, warehouse, and manufacturing environments
- Must be able to wear required PPE, including respirators, safety glasses, goggles, and safety shoes
- Must be available for 2nd shift: Monday-Friday, 3:15-11:45pm
- Must be able to provide line clearance authorization prior to manufacturing and packaging operations
- Must be able to conduct conditional and final release inspections of packaging lines
- Must be able to perform retain sample inspections as required
- Must be able to verify AQL (Acceptable Quality Level) inspections during batch manufacturing and packaging operations
- Must be able to review and approve controlled documents, including manufacturing and packaging batch records
- Must be able to ensure timely and accurate completion of quality-related documentation
- Must be able to support the closure of immediate actions within TrackWise
- Must be able to manage material status and compliance-related transactions within SAP
- Must be able to review cleaning validation protocols and reports
- Must be able to review process validation protocols and reports
- Must be able to support Annual Product Review (APR) data entry and compilation activities as needed
- Must be able to assist with quality improvement initiatives, remediation projects, and other QA-related activities
- Must be able to maintain ownership and accountability for assigned QA processes and projects
- Must be able to provide support across multiple New Jersey facilities as business needs require
- Must be able to partner with Manufacturing, Packaging, Validation, and Quality teams to drive compliance and continuous improvement
Desired Qualifications
- Familiarity with SAP and Learning Management Systems (LMS)
- Knowledge of project management principles, practices, and tools
- Experience working in a global, matrixed, or multicultural organization
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