Quality Assurance Associate

Quality Assurance Associate at Tech Observer Quality Assurance Associate at Tech Observer in Roselle Park, New Jersey Posted in about 22 hours ago.

Type:

full-time

Job Description:

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.