QA Associate: Training & Compliance Expert

Cipla USA Inc.; Fall River (MA); On-site; USD 66,000 - 86,000; Full time

Job summary

Cipla USA Inc. in Fall River, MA is seeking a Quality Assurance Associate focused on Training & Compliance. The role manages quality systems, training governance, and document management to support regulatory compliance and operational excellence.

The position reports to the QA QMS Lead and requires strong cGMP knowledge, CFR Part 11/820 familiarity, and experience with MasterControl. Competitive salary and benefits accompany the role.

Qualifications

• Bachelor’s degree in chemistry, Pharmaceutical Sciences, Quality Management or related field.
• Minimum of two years of experience with New Hire & training Program Management, Site Training Governance, MasterControl & Document Management Leadership and Quality Systems & Change Management.
• Working knowledge and direct application of cGMP and regulatory guidelines related to QA, pharmaceutical manufacturing.
• Familiarity with CFR Part 11 and CFR Part 820 regulations.
• Preferably have prior MDI experience or in Drug Device combination products.

Responsibilities

• Independently initiate, own, and manage change controls related to training systems, document management processes, and Quality Systems improvements.
• Perform impact assessments and risk evaluations for quality system changes and recommend implementation approaches.
• Lead cross-functional change control activities to ensure effective execution, compliance, and timely closure.
• Identify process gaps through audits, trend analysis, investigations, inspection observations, and management review activities.
• Recommend and implement continuous improvement initiatives that reduce compliance risks and improve quality system effectiveness.
• Analyze quality metrics and compliance data to identify emerging trends and provide recommendations to site leadership.
• Support management in establishing quality system objectives, compliance strategies, and training governance initiatives.
• Lead or independently manage projects related to training systems, document management, digital transformation, and quality process improvements.
• Participate in investigations involving training effectiveness, procedural compliance, or document management issues and provide impact assessments and recommendations.
• Provide consultation and guidance to management regarding regulatory expectations, training compliance strategies, and quality system best practices.
• Perform additional quality systems leadership responsibilities as assigned by Head Unit QA and Head Site Quality.

Skills

Quality Systems

Change Management

Training Governance

Document Management

Quality Assurance

Education

Bachelor’s degree in chemistry, Pharmaceutical Sciences, Quality Management or related field

Tools

MasterControl

Job description

Cipla USA Inc. in Fall River, MA is seeking a Quality Assurance Associate focused on Training & Compliance. The role manages quality systems, training governance, and document management to support regulatory compliance and operational excellence.

The position reports to the QA QMS Lead and requires strong cGMP knowledge, CFR Part 11/820 familiarity, and experience with MasterControl. Competitive salary and benefits accompany the role.