Job Description

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

• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or related field (Master’s preferred).
• 8+ years of pharmaceutical QA experience, preferably 8–15 years.
• Minimum 5 years of QA experience in cGMP pharmaceutical manufacturing.
• Strong knowledge of AQA, QC, GLP, GMP, GDP, USP monographs, FDA & ICH guidelines.
• Proficiency with laboratory equipment operation, qualification, and calibration.
• Hands-on experience with regulatory audits and compliance activities.
• Excellent organizational, documentation, and technical writing skills.
• Prior experience with solid oral dosage (tablets, capsules, liquids) required; inhalation products (MDI) experience is a plus.
• Strong communication and leadership skills, able to work independently or in teams.

Work Environment & Other Information

• Must be willing to work in a cGMP laboratory/manufacturing setting.
• Requires PPE (lab coats, safety glasses, hearing protection, etc.).
• Flexibility to work some weekends or holidays if business needs require.
• Relocation support up to $6,000 available.
• No remote work option.

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