QA Associate - Training & Compliance

Cipla • Fall River, MA

1d • Onsite

About The Position

The QA Associate is responsible for quality systems processes, continuous improvement of site 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 supporting regulatory compliance and operational excellence.

The position leads quality systems and change management activities, serves as the site subject matter expert for MasterControl document and training management systems, and manages new-hire training, qualification programs, and site training governance. It also supports quality system projects, regulatory inspections, and consultation with management and departments on regulatory expectations and quality system practices. The role is based in Fall River, Massachusetts, with general working hours of 8:30 a.m. to 5:00 p.m., which may vary based on business needs.

Requirements

• Bachelor’s degree or higher in chemistry, pharmaceutical sciences, quality management, or a related field from an accredited institution.
• At least two years of experience in new-hire and training program management, site training governance, MasterControl and document management leadership, and quality systems and change management.
• Working knowledge and direct application of cGMP and regulatory guidelines related to quality assurance and pharmaceutical manufacturing.
• Relevant understanding and knowledge of CFR Part 11 and CFR Part 820 regulations.

Nice To Haves

• Prior MDI experience or experience with drug-device combination products.

Responsibilities

• Initiate, own, and manage change controls involving 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 support effective execution, compliance, and timely closure.
• Identify process gaps through audits, trend analysis, investigations, inspection observations, and management reviews.
• Recommend and implement continuous improvement initiatives to reduce compliance risks and improve quality system effectiveness.
• Analyze quality metrics and compliance data, identify emerging trends, and provide recommendations to site leadership.
• Support management in establishing quality system objectives, compliance strategies, and training governance initiatives.
• Lead or 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.
• Advise management on regulatory expectations, training compliance strategies, and quality system best practices.
• Perform additional quality systems leadership responsibilities as assigned by the Head Unit QA and Head Site Quality.
• Serve as the site subject matter expert for MasterControl document and training management systems.
• Evaluate MasterControl system issues, user concerns, and process inefficiencies and recommend corrective or preventive actions.
• Assess quality system impacts of document revisions and determine 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.
• Guide departments on document management practices, change implementation strategies, and compliance requirements.
• Partner with global and site stakeholders on MasterControl enhancements, upgrades, and system optimization initiatives.
• Develop, maintain, and improve the site’s new-hire qualification and onboarding program to meet cGMP, regulatory, and business requirements.
• Evaluate training effectiveness using training data, competency assessments, deviations, audit observations, and performance trends, and recommend improvements.
• Assess training requirements for new roles, functions, and organizational changes and recommend qualification pathways.
• Lead training curriculum reviews and recommend modifications to reflect changing regulatory and operational requirements.
• Analyze sitewide training metrics and advise department leadership on compliance trends, overdue training risks, and resource needs.
• Serve as the site subject matter expert for training systems and qualification requirements.
• Advise management on employee qualification status and readiness for critical operations.
• Manage the training matrix structure in MasterControl to align with organizational and regulatory requirements.
• Evaluate requests for job code creation or modification and training assignment changes, and determine implementation strategies.
• Assess training impact associated with new procedures, process changes, organizational changes, and quality system events.
• Lead periodic training program reviews to identify process gaps, compliance vulnerabilities, and improvement opportunities.
• Recommend management actions when training deficiencies, recurring failures, or systemic compliance risks are identified.
• Lead projects to improve training system effectiveness, compliance performance, efficiency, and inspection readiness.
• Participate in regulatory inspections and independently address auditor and inspector inquiries about training systems.
• Detect deviations related to training discrepancies across departments.

Benefits

• The position may be eligible for participation in a performance- and company-results-based bonus program.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level