Specialist QA Shop Floor
Job in
Summit, Union County, New Jersey, 07902, USA
Listed on 2026-10-06
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-10-06
Job specializations:
-
Quality Assurance - QA/QC
Production QC/QA, QA Specialist - Analyst/Manager, Regulatory Compliance Specialist
Job Description & How to Apply Below
QA Shop Floor Specialist responsible for 24/7 quality oversight of manufacturing, QC labs, label, and warehouse operations at a biopharmaceutical site.
Objectives:ensure compliance with cGMP, support manufacturing quality, and facilitate continuous improvement.
Responsibilities:- conduct routine on-the-floor quality checks
- interpret and triage unexpected events
- review batch records
- verify deviations, and act as a designated Authorized Person for release activities per GMP standards.
- Engage in area walkthroughs
- identify quality issues
- support remediation plans
- promote a quality-centric culture
- Collaborate with cross-functional teams and participate in shift meetings.
- Bachelor's in STEM or equivalent experience
- 2+ years of cGMP experience
- including 1+ years in manufacturing
- with knowledge of FDA/EMA regulations in biopharma or cell therapy.
decision-making, problem-solving, GxP systems (MES, SAP), and digital tools (Power Automate, Tableau).
Preferred:experience with aseptic processes, quality management systems, and working in cleanroom environments.
Reporting:to the Manager, QA Shop Floor.
Work Setup:multiple shifts (days and nights), on-site.
High-value Specifics:biopharma manufacturing, cGMP compliance, quality assurance in sterile and aseptic environments.
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