Senior Quality Associate

Job requirements

• Bachelor’s degree in Life Sciences, or a related field preferred; equivalent work experience may be considered.

• Minimum 2+ years of experience in quality assurance within a regulated industry.

• Knowledge of quality systems: deviation management, corrective and preventative actions, change control, and document management.

• Experience with routine FDA regulatory inspections preferred.

• Experience with electronic platforms (e.g., Veeva, Kneat) preferred.

• Excellent organizational and communication skills.

• Detail-oriented with a commitment to compliance and quality

• Knowledge of Quality principles, concepts, systems, industry practices, and standards in relation to document management, training, change control, deviations and corrective/preventive actions.

• Understanding of Good Manufacturing Practices (GMP) and applicable regulatory expectations for documentation in the industry.

• Strong proficiency with electronic document management systems and Microsoft Office Suite (Word, Excel).

• Excellent attention to detail, organizational skills, and ability to manage multiple priorities.

• Effective verbal and written communication skills; ability to interface across the organization.

• Proven ability to work both independently and collaboratively in a team environment.

Job responsibilities

• Maintain robust document management practices, ensuring controlled documents are accurate, current, and complaint

• Review and approve deviations, CAPAs, and change controls ensuring robust root cause analysis and timely closure

• Support day to day manufacturing and QC operations by issuing logbooks, forms, batch records, and labels.

• Develop and revise SOPs, work instructions, and templates related to quality systems

• Support Management Review including compiling appropriate metrics

• Provide training and guidance to staff on quality systems and best practices

• Identify quality risks, compliance gaps, improvement opportunities, and drive continuous improvement initiatives

• Support inspection readiness activities

• Monitor quality trends and appropriately escalate risks to Quality Leadership

• Promote a culture of quality, transparency, and accountability

• Perform other duties as assigned

Job benefits