Senior Quality Specialist (Contract) — GMP Compliance

Intellectt Inc; Morris Plains (NJ); On-site; USD 34,440 - 61,992; Full time

Job summary

A leading pharmaceutical company is seeking two Senior Quality Specialists on a contract basis to ensure quality assurance and compliance support for clinical products. Responsibilities include detailed batch review, leading quality systems processes, and collaborating cross-functionally. Ideal candidates will have a Bachelor's degree in a relevant field and at least 5 years of GMP experience. This is a crucial role in advancing clinical products and requires strong knowledge of GMP regulations.

Qualifications

• 5+ years of relevant Quality Assurance work experience in a GMP pharmaceutical or biotech environment.
• Hands-on QA experience in an analytical or manufacturing setting preferred.
• Knowledge of cGMPs and their application across the product lifecycle.

Responsibilities

• Perform detailed review of executed batch documentation for drug products.
• Support or lead quality system processes and investigations.
• Collaborate with colleagues from various departments.

Skills

GMP regulations

Root Cause Analysis (RCA)

Quality Assurance

Continuous improvement

Education

Bachelor’s degree in a scientific or allied health field

Job description

A leading pharmaceutical company is seeking two Senior Quality Specialists on a contract basis to ensure quality assurance and compliance support for clinical products. Responsibilities include detailed batch review, leading quality systems processes, and collaborating cross-functionally. Ideal candidates will have a Bachelor's degree in a relevant field and at least 5 years of GMP experience. This is a crucial role in advancing clinical products and requires strong knowledge of GMP regulations.