We're looking for a Quality Assurance Compliance Associate, working in the Pharmaceuticals & Medical Products industry in Ridgefield, New Jersey, United States.
Reviews manufacturing BPR (batch production records) to ensure compliance with internal specifications and cGMPs.
Assures documentation is in compliance with cGMP regulations and ISO 13485 guidelines.
Drafts and reviews specifications and SOPs.
Monitors and trends batch record errors and assists Quality Assurance management with metrics.
Assists departments with Packaging process improvement projects.
Provides Quality Investigation Group with BPRs and QC data to support deviations and customers complaints investigation closure.
Performs real time batch record review and release.
Maintains and completes non-conformances containment tasks using the Track Wise and SAP system.
Deals with supplier issues as needed using SAP to run genealogy reports.
Performs line clearances and support packaging activities.
Navigates various computer platforms (Live Link, StarLiMs, SAP and Track Wise).
Our client is an award-winning clinical development company. Improving lives globally with 20+ years’ experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
Bachelors degree with 1-4 years experience
Experience writing and reviewing SOPs/Investigations
Able to navigate various computer platforms (LiveLink, StarLIMs, SAP and TrackWise)
Familiar with AQL sampling, normal, reduced, and tightened inspections and switching rules
The pay range we're offering is 23 - 28 per hour. This position may present an opportunity to go permanent.
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible? Apply here.