Onsite QA Stability Associate - Data-Driven Quality

englewoodlab; Paterson (NJ); On-site; USD 23,000 - 29,000; Full time

Benefits offered by this job

Medical Insurance

401(k) with company match

Paid Time Off

Holiday pay

Job summary

Englewood Lab in Totowa, NJ is seeking a QA Associate – Stability to support the OTC drug stability program onsite. You will coordinate stability studies, manage sample pulls and shipments, monitor chambers, and review data to ensure accuracy and compliance with cGMP, ISO 22716 and ICH guidelines.

The role combines data review, documentation and collaboration with QA, manufacturing, R&D and external labs, with a Monday–Friday full-time schedule and competitive hourly pay.

Qualifications

• Associate's degree in a scientific discipline or equivalent experience.
• 0–2 years of QA, QC, stability, or laboratory operations in GMP environment; internship or co-op counts.
• Familiarity with cGMP (21 CFR 210/211) and ISO 22716; knowledge of ICH stability guidelines is a plus.
• Understanding of good documentation practices and data integrity (ALCOA+).
• Proficiency with MS Word, Excel and PowerPoint; ERP/LIMS experience is a plus.

Responsibilities

• Maintain the master stability schedule and tracking of pulls, storage conditions and study points.
• Coordinate sample storage, pulls, shipments to internal/external labs and audit trails.
• Review stability data for completeness and assist in stability protocol development and deviations investigations.
• Support stability investigations, CAPAs and change controls related to stability studies.
• Document and archive stability records and contribute to SOPs and study summaries.

Skills

Attention to detail

Written & verbal communication

Data integrity

Documentation

Education

Associate's degree in a scientific discipline

Tools

ERP

LIMS

Job description

Englewood Lab in Totowa, NJ is seeking a QA Associate – Stability to support the OTC drug stability program onsite. You will coordinate stability studies, manage sample pulls and shipments, monitor chambers, and review data to ensure accuracy and compliance with cGMP, ISO 22716 and ICH guidelines.

The role combines data review, documentation and collaboration with QA, manufacturing, R&D and external labs, with a Monday–Friday full-time schedule and competitive hourly pay.