JOB DESCRIPTION:

The Quality Associate plays a key role within the manufacturing team by ensuring inspection readiness, maintaining site quality systems, and driving compliance with cGMP standards and health authority requirements. This position supports manufacturing operations through proactive oversight of quality systems, risk management, and continuous improvement initiatives.

Requirements:

• Bachelor’s degree (or equivalent) in a scientific or engineering discipline.
• Minimum 2 years of experience in pharmaceutical manufacturing within a Quality Assurance role.
• Strong knowledge of cGMP, GDP, data integrity, and regulatory compliance.
• Experience with electronic Quality Management Systems such as TrackWise and/or Veeva.
• Demonstrated knowledge and application of ISPE C&Q and ASTM E2500 principles.
• Experience in API facility or unit operations (e.g., batch/continuous reactions, filtration, chromatography, centrifugation, drying, utilities, cleanrooms, air handling systems).
• Previous exposure to MES systems (e.g., Syncade), Kneat, and/or Val Genesis.
• ASQ Certification (or equivalent).
• Background in Computer System Quality Assurance (CSQA)

GMP Documentation & Validation:

• Review and approve GMP documentation, including qualification and validation deliverables (e.g., change controls, IQ/OQ/PQ protocols, equipment validation, computer systems, logbooks, and product quality evaluations).
• Ensure systems, processes, and equipment remain in a validated state and compliant with regulatory commitments.

Compliance Oversight:

• Monitor and maintain all aspects of GMP compliance across assigned areas.
• Interpret and apply emerging regulatory and GMP guidelines to site quality systems and programs.
• Prepare, maintain, and update site-level quality system policies and procedures.
• Maintain a regular presence on the production floor to oversee compliance and drive GMP culture.

Quality Systems Management:

• Review and approve deviations, change controls, investigations, and product quality complaints.
• Assess deviations for impact on product quality and equipment qualification, ensuring robust root cause analysis and effective CAPA implementation.
• Support and participate in Quality Risk Management activities (e.g., FMEAs).
• Escalate critical quality issues to management as appropriate.

Audits & Inspections:

• Participate in site self-inspection programs and audits to ensure compliance with quality system policies and regulatory standards.
• Support inspection readiness activities across all manufacturing operations.

Training & Communication:

• Educate and communicate GMP requirements, policies, and regulations to personnel.
• Promote a culture of compliance, accuracy, and continuous improvement within operations.
• Technical Knowledge & Development.
• Develop an in-depth understanding of site manufacturing processes, facilities, utilities, and quality systems.
• Build knowledge of key operations, including equipment, procedures, and personnel expertise.

Requirements:

• Bachelor’s degree (or equivalent) in a scientific or engineering discipline.
• Minimum 2 years of experience in pharmaceutical manufacturing within a Quality Assurance role.
• Strong knowledge of cGMP, GDP, data integrity, and regulatory compliance.
• Experience with electronic Quality Management Systems such as TrackWise and/or Veeva.
• Demonstrated knowledge and application of ISPE C&Q and ASTM E2500 principles.
• Experience in API facility or unit operations (e.g., batch/continuous reactions, filtration, chromatography, centrifugation, drying, utilities, cleanrooms, air handling systems).
• Previous exposure to MES systems (e.g., Syncade), Kneat, and/or Val Genesis.
• ASQ Certification (or equivalent).
• Background in Computer System Quality Assurance (CSQA).