QA Associate

Job Title: Manufacturing QA Associate

Location: Fall River, MA

Job Type: Full-Time On-site

Work Schedule: General Shift (8:30 AM – 5:00 PM; may vary based on business needs)

Salary Range: $62,400 - $75,400

Experience Required: 2 - 15 Years

FLSA Classification: Exempt, Professional

Position Overview

We are seeking a Manufacturing Quality Assurance (QA) Associate with experience in warehouse and pharmaceutical operations to support quality oversight and compliance activities in a cGMP-regulated environment. The ideal candidate will ensure that all processes, materials, and products meet established quality standards and comply with applicable regulations.

Key Responsibilities

Ensure all products and materials are stored in compliance with Good Distribution Practices (GDP) and Good Manufacturing Practices (GMP), including temperature and humidity control.

Oversee the handling of printed packaging materials, raw material dispensing, and the control of expired or rejected materials.

Monitor packaging and labeling for accuracy and compliance with regulatory requirements.

Participate in and support internal and external audits; assist in the development and implementation of Corrective and Preventive Actions (CAPAs).

Maintain compliance with Standard Operating Procedures (SOPs) and workplace safety regulations.

Review warehouse logbooks and documents for accuracy and completeness.

Perform routine checks of cleanliness and sanitation in warehouse areas.

Ensure accurate inventory tracking using ERP systems such as SAP.

Verify proper storage and handling of specialized pharmaceutical products, including controlled substances and temperature-sensitive items.

Conduct periodic checks to ensure First-In, First-Out (FIFO) stock rotation.

Provide training to warehouse staff on quality and compliance procedures.

Collaborate with warehouse and quality leadership to implement continuous improvements in warehouse QA processes.

Investigate quality incidents or deviations and assist in root cause analysis.

Coordinate with supply chain, production, and other departments to resolve quality-related issues efficiently.

Monitor warehouse conditions for sanitation, contamination prevention, and employee safety.

Perform any additional activities as assigned by department leadership.

Required Qualifications

Education:

Advanced vocational training or a degree in pharmaceutical manufacturing, industrial management, or a related field preferred.

Experience:

Minimum of 2 years of quality assurance experience in a cGMP pharmaceutical manufacturing setting.

Experience in Warehouse QA is strongly preferred.

Familiarity with dosage forms such as liquids, solids, tablets, capsules is required.

Experience with MDI (Metered Dose Inhalers) or parenterals is a plus.

Technical Skills:

Proficient with Microsoft Office tools and inventory management systems such as SAP.

Strong understanding of current Good Manufacturing Practices (cGMP) and documentation standards.

Communication Skills:

Must be proficient in reading, writing, and speaking English.

Strong interpersonal and organizational skills.

Preferred Experience

Exposure to a warehouse or manufacturing QA environment in a regulated pharmaceutical setting.

Experience in performing internal audits or supporting external inspections.

Familiarity with quality systems and improvement methodologies.

Professional & Behavioral Competencies

Able to work independently and as part of a team.

Capable of multitasking and meeting deadlines in a fast-paced environment.

Strong attention to detail and problem-solving abilities.

Must demonstrate initiative, accountability, and a commitment to compliance and quality.

Physical Requirements

Standing or walking unassisted for over 75% of an 8-hour shift.

Lifting up to 10 kg unassisted may be required.

Sitting at a desk and working at a computer for extended periods.

Use of appropriate personal protective equipment (PPE) is mandatory.

Work Environment

This role operates in a cGMP pharmaceutical manufacturing and warehouse environment.

Work involves handling solvents, powders, or materials typically used in pharma manufacturing.

May be assigned to any shift depending on business needs; occasional weekend or holiday work may be required.

Remote work is not available for this role.

Work Authorization

U.S. Citizens or Green Card Holders only.

Visa sponsorship is not available.