Stability QA Specialist – GMP & Data Integrity

Englewood Lab; Totowa (NJ); In loco; USD 48.712.000 - 60.174.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical, Dental & Vision Insurance

401(k) with Company Match

Paid Time Off (PTO)

Paid Company Holidays

Special Paid Leave for Personal Events

Descrizione del lavoro

Englewood Lab is seeking a QA Associate – Stability to support the OTC drug stability program onsite in Totowa, NJ. You will maintain the stability schedule, coordinate sample storage, pulls, and shipments to internal and external labs, and assist with stability protocols and reports.

The role requires an Associate's degree in a scientific discipline, 0–2 years in QA, QC, or GMP environments, familiarity with cGMP and ISO 22716, and strong attention to data integrity, documentation, and

Competenze

• Associate's degree in a scientific discipline or equivalent mix of education and experience.
• 0–2 years in QA, QC, stability, or GMP-regulated lab operations; OTC/pharma preferred.
• Knowledge of cGMP (21 CFR 210/211) and ISO 22716; ICH stability guidelines a plus.
• Strong attention to detail, organization, and cross-functional collaboration.

Mansioni

• Maintain stability program calendar, sample pulls, and storage coordination.
• Support stability chamber monitoring, excursions, and documentation.
• Review stability data for accuracy and trends in accordance with protocols.
• Assist investigations into stability deviations and OOS/OOT results.
• Ensure stability records meet data integrity standards and audit readiness.
• Support change control and documentation за stability processes.

Conoscenze

Attention to detail

Written communication

Verbal communication

Analytical skills

Organization

Cross-functional collaboration

Formazione

Associate's degree in scientific discipline

Strumenti

Excel

Word

PowerPoint

Descrizione del lavoro

Englewood Lab is seeking a QA Associate – Stability to support the OTC drug stability program onsite in Totowa, NJ. You will maintain the stability schedule, coordinate sample storage, pulls, and shipments to internal and external labs, and assist with stability protocols and reports.

The role requires an Associate's degree in a scientific discipline, 0–2 years in QA, QC, or GMP environments, familiarity with cGMP and ISO 22716, and strong attention to data integrity, documentation, and