Overview
Quality Assurance Associate II (GMP) Jobs in Rahway, NJ at AllSTEM Connections
Title: Quality Assurance Associate II (GMP)
Company: AllSTEM Connections
Location: Rahway, NJ
Title: Quality Assurance Associate II (GMP)
Pay Rate: $39/ HR. With Benefits
Location: Rahway, NJ
Duration – 12 Months
Shift Time – Standard Shift
Job Summary
The Quality Assurance Associate II (GMP) will support the Global Development Quality Operations (GDQ Ops) team by providing Quality Assurance oversight for clinical-stage drug product manufacturing, testing, and release activities. This role ensures compliance with cGMP regulations, ICH guidelines, and company quality standards while supporting batch disposition, batch release, quality systems, documentation, compliance, and continuous improvement initiatives.
Must-Have Requirements
- Minimum 3 years of experience in the pharmaceutical industry.
- Hands-on experience with Batch Disposition, Batch Release, or Quality Assurance in a GMP/cGMP regulated environment.
- Strong understanding of Good Manufacturing Practices (GMP) and quality systems.
- Self-starter with the ability to work independently, take initiative, and manage changing priorities with minimal supervision.
- Experience with SAP and Veeva is highly preferred.
- Excellent communication, collaboration, and organizational skills.
- Bachelor's degree in Life Sciences or Engineering (Biology, Microbiology, Biochemistry, Chemistry, Chemical Engineering, Biomedical Engineering, or related discipline).
Key Responsibilities
- Perform independent quality review of batch production records, laboratory testing data, and supporting documentation.
- Review and approve batch records for product disposition and batch release/rejection.
- Review and approve GMP documents including deviations, investigations, analytical method validations, method transfers, specifications, certificates of analysis (CoA), and related documentation.
- Support product release activities in compliance with cGMP requirements.
- Review quality documents and prepare materials for internal and external audits.
- Participate in daily tier meetings, team meetings, and cross-functional discussions.
- Support warehouse quality operations and assist with troubleshooting quality-related issues.
- Collect, analyze, and report quality metrics.
- Maintain GMP documentation in SAP, Veeva, and other electronic quality systems.
- Support compliance activities, inspection readiness, CAPAs, quality risk management, and continuous improvement projects.
- Develop, review, and update SOPs and other controlled GMP documents.
- Coordinate meetings, document meeting minutes, and communicate project updates.
- Collaborate daily with Quality Assurance, Warehouse, Laboratory, Manufacturing, Regulatory, and other cross-functional teams.
- Perform additional quality-related responsibilities as assigned.
Required Qualifications
Education
- Bachelor's degree (B.S.) in Life Sciences or Engineering, including:
- Biology
- Microbiology
- Biochemistry
- Chemistry
- Chemical Engineering
- Biomedical Engineering
- Related scientific discipline
Experience
- Minimum 3 years of experience in the pharmaceutical, biotechnology, medical device, chemical, or other GMP-regulated industry.
- Experience with Quality Assurance, Batch Record Review, Batch Disposition, and Batch Release.
- Experience working in a regulated GMP/cGMP environment.
- Knowledge of clinical supply, drug product manufacturing, or R&D quality processes is preferred.
Required Skills
- Good Manufacturing Practices (GMP/cGMP)
- Batch Record Review
- Batch Disposition
- Batch Release
- Quality Assurance
- Document Review
- Deviation & Investigation Review
- CAPA
- Change Control
- Quality Risk Management
- Audit & Inspection Support
- SOP Development & Review
- Root Cause Analysis
- Microsoft Office Suite (Word, Excel, PowerPoint, Teams)
- SAP (Preferred)
- Veeva (Preferred)
Work Environment
- Location: Rahway, NJ
- Work Schedule: 100% Onsite
- Collaborate daily with approximately 10 cross-functional team members, including Quality, Warehouse, Laboratory, Manufacturing, and other operational partners.
- Fast-paced GMP environment requiring strong attention to detail, adaptability, and the ability to manage multiple priorities.
