Analytical QA Supervisor

Job Title: Analytical Quality Assurance Supervisor

Location: Fall River, MA (On-site only)

Employment Type: Full-Time, Exempt

Work Hours: General Shift – 8:30 AM to 5:00 PM (May vary depending on business needs)

Position Overview:

This position is ideal for candidates with a strong analytical chemistry background and proven experience in analytical quality assurance within a regulated pharmaceutical manufacturing environment. The role involves monitoring compliance across laboratory operations, managing documentation, conducting internal audits, and supporting regulatory submissions.

Key Responsibilities:

Confirm and ensure compliance of method validation/verification/comparison protocols and reports.

Monitor adherence to current Good Laboratory Practices (cGLP) during routine lab operations.

Verify Standard Operating Procedures (SOPs), test methods, and process validation documents.

Coordinate with Regulatory Affairs and Analytical Labs to ensure timely documentation for ANDA submissions.

Track, maintain, and archive incoming documentation appropriately.

Review and approve laboratory raw data, including audit trail assessments.

Identify and report system gaps and support improvements in compliance and efficiency.

Participate in laboratory investigations and ensure corrective actions are implemented.

Review and assess raw materials, in-process, and finished product analytical documents for compliance.

Conduct random internal audits of the analytical lab and ensure corrective actions where needed.

Monitor and implement Pharmacopoeial changes (USP, EP, JP, etc.).

Support cross-functional and departmental projects as assigned.

Education & Experience Requirements:

Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or a related field (Required)

Master’s degree in a relevant field (Preferred)

8–15 years of experience in pharmaceutical manufacturing in Quality Assurance

Minimum 5 years specifically in Analytical QA under cGMP regulations

Strong knowledge of:

Analytical lab practices (API, drug products, analytical development)

FDA, ICH guidelines, USP monographs

Analytical instruments and software: HPLC, UV-Vis, GC, pH meter, Potentiometer, Stability Chambers, etc.

Proficient in Microsoft Office and Quality Systems software

Hands-on experience with audit trail reviews, documentation systems, and investigations

Preferred Experience:

Experience working with inhalation products such as MDI

Experience in root cause investigations and regulatory audit support

Competencies & Skills:

Strong analytical thinking and attention to detail

Excellent written and verbal communication skills

Effective interpersonal and team collaboration skills

Ability to influence decisions and support change implementation

Strong documentation and technical writing skills

Capable of working independently and under minimal supervision

Fluent in English (reading, writing, and speaking)

Work Conditions:

Must be willing to work in a pharmaceutical manufacturing and laboratory environment

Must wear appropriate PPE (lab coats, gloves, safety glasses, etc.)

May require standing, walking, and lifting up to 35 lbs

Must be available for occasional weekends or adjusted shifts depending on business needs

Relocation assistance may be negotiable

Remote work is not available