QA Supervisor

Job Title: Analytical QA Supervisor

Location: Fall River, MA

Job Type: Full-Time On-site

Work Schedule: General Shift: 8:30 AM – 5:00 PM (subject to business needs)

Experience Required: 5 - 15 Years

Position Overview

We are seeking an experienced Analytical Quality Assurance (QA) Supervisor with a solid background in analytical chemistry and pharmaceutical quality systems. The ideal candidate will support analytical QA operations in a cGMP pharmaceutical manufacturing environment, ensuring compliance with applicable regulatory requirements and internal quality standards.

Key Responsibilities

Review and ensure compliance of method validation, method verification, and comparison study reports.

Monitor adherence to current Good Laboratory Practices (cGLP) in the analytical lab.

Review and verify Standard Operating Procedures (SOPs), test methods, and validation protocols.

Coordinate with Regulatory Affairs and Analytical Labs for timely document submissions supporting ANDAs.

Maintain and track QA documentation and ensure appropriate archival practices.

Review laboratory raw data including audit trails for accuracy and compliance.

Identify gaps in quality systems and recommend improvements.

Participate in and support laboratory investigations and compliance-related incidents.

Review documentation for raw materials, in-process, and finished products for QA compliance.

Conduct internal audits of the analytical lab and ensure corrective actions are taken.

Evaluate and implement updates from pharmacopoeial changes (USP, EP, etc.).

Support cross-functional QA projects and initiatives as assigned.

Required Qualifications

Education:

Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or related field (required).

Master’s degree (preferred).

Experience:

Minimum 5 years of quality assurance experience in a cGMP-compliant pharmaceutical manufacturing environment.

8-15 years of total experience in pharmaceutical manufacturing preferred.

Technical Skills:

Solid knowledge of Analytical QA (AQA) practices.

Familiarity with laboratory instruments such as HPLC, GC, UV-Vis, pH meter, Stability chambers, etc.

Strong working knowledge of FDA and ICH guidelines, USP monographs, and documentation practices (GLP/GMP/GDP).

Communication Skills:

Proficient in reading, writing, and speaking English.

Excellent documentation and technical writing skills.

Systems & Tools:

Proficient with Microsoft Office (Word, Excel, PowerPoint).

Experience with QA software or document management systems is a plus.

Preferred Experience

Exposure to MDI (Metered Dose Inhaler) manufacturing is a strong plus.

Experience with oral solid dosage forms (tablets, capsules), liquids, and other dosage forms is also valued.

Familiarity with regulatory inspections and audit readiness processes.

Professional Competencies

Strong organizational skills with attention to detail.

Ability to work independently and in cross-functional teams.

Demonstrated ability to lead quality initiatives and process improvements.

Effective at troubleshooting, root cause analysis, and corrective/preventive action planning.

Self-starter with a proactive approach to continuous learning and quality enhancement.

Work Environment & Conditions

Must be willing to work on-site at the pharmaceutical manufacturing facility.

Occasional weekend or holiday work may be required depending on business needs.

Must be able to wear appropriate PPE (lab coats, safety glasses, respirators, etc.) in a cGMP laboratory environment.

Relocation assistance is negotiable; remote work is not supported.

Work Authorization

U.S. Citizens or Green Card Holders only.

No visa sponsorship available.