QA Training & Compliance Specialist

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

Job summary

Cipla in Fall River, MA is seeking a Quality Assurance Associate focused on Training & Compliance. You will own quality system initiatives, manage training and document controls, and drive regulatory alignment for cGMP requirements.

Expect two years of related experience, collaboration with QA QMS Lead, and a role that advances operational excellence across training programs and MasterControl platforms.

Qualifications

• Bachelor’s degree in chemistry, pharmaceutical sciences or quality management is required.
• Minimum 2 years of experience in New Hire & training program management and quality systems.
• Strong knowledge of cGMP and CFR parts 11 and 820 is expected.

Responsibilities

• Lead quality systems and change management for training and document management.
• Perform impact assessments and risk evaluations for quality system changes.
• Guide cross-functional change control activities to ensure compliance and timely closure.
• Identify process gaps via audits and trend analyses, with recommendations for improvements.
• Analyze quality metrics to identify trends and advise site leadership on actions.
• Manage training governance, qualification requirements, and regulatory training needs.
• Participate in investigations related to training effectiveness and compliance.
• Act as site SME for MasterControl and training management systems.

Skills

cGMP knowledge

Regulatory CFR 11/820 knowledge

Quality systems

Training program management

Education

Bachelor's degree in Chemistry/Pharmaceutical Sciences/Quality Management

Job description

Cipla in Fall River, MA is seeking a Quality Assurance Associate focused on Training & Compliance. You will own quality system initiatives, manage training and document controls, and drive regulatory alignment for cGMP requirements.

Expect two years of related experience, collaboration with QA QMS Lead, and a role that advances operational excellence across training programs and MasterControl platforms.