MFG QA Associate

Job Title: MFG QA Associate

Location: Fall River, MA

Employment Type: Full-Time, Exempt

Shift Hours: 8:30 AM – 5:00 PM (may vary based on business needs)

Job Purpose:

The Manufacturing QA Associate is responsible for ensuring warehouse and production processes comply with regulatory standards, internal quality systems, and safety requirements. The role ensures that pharmaceutical products meet all applicable quality, safety, and compliance benchmarks throughout the manufacturing and distribution cycle.

Key Responsibilities:

Verify proper storage conditions (temperature, humidity, etc.) for products/materials in line with GMP and GDP.

Oversee handling, labeling, and dispensing of printed packaging materials and raw/packaging materials, including expired/rejected goods.

Participate in internal/external audits and support CAPA implementation.

Review warehouse logbooks and quality documentation for compliance.

Conduct quality checks on warehouse cleanliness and process adherence.

Monitor stock rotations (FIFO), expiry checks, and batch control activities.

Ensure correct storage and handling of controlled substances and temperature-sensitive items.

Maintain inventory tracking systems, e.g., SAP.

Train warehouse staff on SOPs, safety practices, and quality standards.

Drive continuous improvement of quality management systems and processes.

Coordinate with cross-functional departments (Production, Supply Chain, Distribution) to resolve quality issues.

Investigate non-conformities and support timely corrective actions.

Monitor facility for compliance with sanitation and contamination control standards.

Perform other duties as assigned by department leadership.

Qualifications:

Education:

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

Experience:

Minimum 2 years of experience in QA within a GMP-regulated pharmaceutical manufacturing or warehouse environment.

Prior experience in Warehouse QA is preferred.

Technical Competencies:

Strong working knowledge of cGMP, GDP, and regulatory guidelines.

Skilled in Microsoft Office, SAP, and documentation systems.

Familiarity with SOPs, deviation management, CAPAs, and inventory control.

Effective communication and interpersonal skills.

Able to work independently and within cross-functional teams.

Solid problem-solving and decision-making abilities.

Behavioral & Professional Expectations:

Must be willing to work onsite (no remote work available).

Must be open to occasional weekend work as required.

Must be detail-oriented, proactive, and able to handle regulatory audits or inspections.

Professional conduct and a collaborative attitude are essential.

Physical & Work Environment Requirements:

Ability to stand/walk for 75% or more of an 8-hour shift.

Ability to lift up to 10 kg unassisted.

Ability to work in cGMP manufacturing environments with PPE (lab coats, safety glasses, gloves, respirators, etc.).

Exposure to solvents, powders, and chemicals typical in pharmaceutical settings.

May be required to work alternate shifts or weekends/holidays depending on business needs.