Overview
Quality Assurance Associate Jobs in Millburn, NJ at Tech Observer
Title: Quality Assurance Associate
Company: Tech Observer
Location: Millburn, NJ
Position – QA Operations Associate
Location – Millburn, NJ (Onsite)
Contract – 12 Months with a possibility of extension
Shift Schedule:
- Week 1: Sunday – Wednesday | 6:00 AM – 5:30 PM
- Week 2: Sunday – Tuesday | 6:00 AM – 6:30 PM
- Must be flexible to work 36–42 hours/week
Job Overview:
The QA Operations Associate will support Quality Assurance activities and ensure compliance with GxP standards and Quality Management Systems within a pharmaceutical manufacturing environment. This role provides shop floor quality oversight across production, quality control, and supply chain operations while supporting batch release and continuous quality improvement initiatives.
Key Responsibilities:
- Provide QA oversight for manufacturing, quality control, and supply chain operations to ensure compliance with cGMP and data integrity requirements.
- Support batch release activities and QA shop floor programs including ViMOS, GEMBA walkthroughs, media fill oversight, area release, and event triage.
- Review manufacturing and packaging batch records and escalate discrepancies promptly.
- Perform facility alarm reviews and assess potential GxP impact.
- Support raw material disposition activities and ensure compliance with GMP procedures.
- Oversee final product dose storage after manufacturing completion.
- Assist during FDA/regulatory inspections and support regulatory submissions.
- Partner with Production, Engineering, and Supply Chain teams to support continuous quality improvement initiatives.
- Ensure timely escalation of quality incidents and operational concerns.
Required Qualifications:
- Bachelor’s Degree in Life Sciences, Chemistry, or related scientific field.
- 2+ years of experience in GxP biopharmaceutical or API manufacturing operations.
- 1+ years of Quality Assurance experience preferred.
- Experience in QA/QC within pharmaceutical manufacturing environments.
- Knowledge of environmental monitoring and classified cleanliness zones.
- Strong communication, teamwork, and cross-functional collaboration skills.
Work Environment & PPE Requirements:
- Position is considered a radiation worker role.
- Must wear PPE, including lab coat, hairnet, beardnet, coveralls, hood, booties, hard hats, and other safety equipment.
- Requires 2–3 hours of daily oversight in fully gowned production areas.
- Must be comfortable working in a regulated pharmaceutical manufacturing environment.
