Analytical QA Supervisor (Fall River)

Job Title : Analytical QA Supervisor

Location : Fall River, MA

Job Type : Full-Time, On-Site

Schedule : General hours 8 : 30 AM 5 : 00 PM (may vary based on business needs)

Compensation : (based on experience)

Position Overview

We are seeking an experienced Analytical QA Supervisor with a strong background in analytical chemistry and laboratory operations. The ideal candidate will bring expertise in cGMP pharmaceutical manufacturing environments, Quality Assurance (QA), and analytical quality assurance (AQA). This role ensures compliance with laboratory practices, oversees documentation, audits processes, and supports regulatory submissions.

Key Responsibilities

• Review and approve method validations, verifications, and analytical reports.
• Ensure adherence to current Good Laboratory Practices (cGLP) and SOPs.
• Verify process validation and characterization-related documentation.
• Partner with Regulatory Affairs and Analytical Laboratory teams for timely submissions.
• Maintain accurate tracking, archival, and compliance of laboratory documentation.
• Conduct internal audits, investigations, and root cause analyses in the analytical lab.
• Review raw data, audit trails, and identify gaps for improvement.
• Support regulatory and compliance audits at local and federal levels.
• Assess and implement pharmacopoeia changes as required.
• Provide technical support on laboratory instruments such as HPLC, GC, UV, pH meter, and stability chambers.

Qualifications

Work Environment & Other Information