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.
Skills: pharmaceutical manufacturing,microsoft office tools,materials,problem-solving abilities,compliance,good manufacturing practices (gmp),interpersonal skills,warehouse qa,good distribution practices (gdp),organizational skills,sap,management,quality assurance,packaging,erp systems,leadership,manufacturing
