QA Associate - Training & Compliance

NOTICE:
The posting for local applicants only - is not for those applying for a global assignment and/or for employees working outside of Cipla's U.S. Subsidiaries or Affiliates.

Quality Assurance Associate - Training & Compliance

Fall River, MA

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

QA QMS Lead

$66,300 - $86,000

The QA Associate is responsible for the quality systems processes, continuous improvement of the site's training, strategic administration and document management. The role independently manages quality system initiatives, evaluates training effectiveness and compliance risks, leads process improvement activities, provides recommendations to management, and serves as a key quality systems resource to support regulatory compliance and operational excellence.

• 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.

• Serve as site SME for Master Control document and training management systems.
• Independently evaluate system issues, user concerns, and process inefficiencies and recommend corrective or preventive actions.
• Assess quality system impacts of document revisions and determine appropriate implementation and training strategies.
• Lead document control process improvement initiatives to enhance compliance, efficiency, and user experience.
• Review audit trail trends, identify potential compliance concerns, perform impact assessments, and recommend remediation plans.
• Provide guidance to departments regarding document management practices, change implementation strategies, and compliance requirements.
• Partner with global/site stakeholders to support Master Control enhancements, upgrades, and system optimization initiatives.

• Develop, maintain, and continuously improve the site's new hire qualification and onboarding program to ensure compliance with cGMP, regulatory, and business requirements.
• Evaluate training effectiveness through periodic review of training data, competency assessments, deviations, audit observations, and performance trends, and recommend improvements to management.
• Independently assess training requirements for new roles, functions, and organizational changes and recommend qualification…