Quality Assurance Specialist

About the Role

Key Responsibilities

• Review and approve laboratory data, standard operating procedures (SOPs), validation specifications and other quality documentation for completeness, accuracy, and compliance with regulatory standards (e.g. FDA, ICHGCP).
• Conduct audits and inspections to assess compliance with applicable regulations (e.g. FDA, ICH) and company procedures.
• Investigate nonconformances from established procedures and protocols and implement corrective and preventative actions (CAPA) to prevent recurrence.
• Analyze data and generate reports to identify quality trends and areas for improvement.
• Participate in the development, implementation, and maintenance of quality systems and procedures.
• Participate in the development and implementation of quality improvement initiatives.
• Maintain a comprehensive understanding of relevant regulations and quality standards (e.g., FDA, EMA, ICH).
• Review training record compliance and report any discrepancies or shortcomings.
• Provide guidance and training to personnel on quality procedures, documentation practices, and regulatory requirements.
• Provide quality support to other departments, including laboratory personnel on quality-related matters.
• Participate in data analysis and reporting activities.
• Maintain accurate and complete quality documentation, ensuring proper recordkeeping.
• Support external audits and inspections.
• Perform internal and external quality audits, to ensure adherence to quality standards and contractual agreements.

Requirements

• Bachelor's degree with life sciences related major is preferred.
• Generally, 5+ years of professional work experience in a Quality Assurance/Control role in the life sciences industry.
• Knowledge of quality tools/concepts and their application such as Document Control/Change Control, Corrective/Preventive Action, Internal Audits, Computer System Validation, etc.
• Working experience with eQMS, ERP systems and other information systems.
• Excellent attention to detail and strong analytical skills.
• Excellent communication and interpersonal skills, with the ability to work effectively in a team environment.
• Ability to work independently and prioritize tasks in a fast-paced environment.

Nice to Have

• Experience with regulatory standards such as FDA, EMA, ICH.
• Experience supporting client audits and inspections.
• Familiarity with laboratory data review and validation processes.

Qualifications

• Bachelor's degree in a life sciences related major (preferred).
• 5+ years of professional experience in QA/QC in the life sciences industry.

Benefits & Perks

• Competitive salary and benefits package options including free medical, dental, vision, life, and disability which start on your first day of employment.
• 401(k) match program which starts on your first day of employment.
• Generous vacation and paid time off, including your birthday, paid parental leave, paid family leave, etc.
• Professional development opportunities and reimbursement for relevant certifications.
• Collaborative and inclusive work environment that values diversity.
• Team-building activities and social events.
• Employee Referral Program and Colleague Recognition Program.