Senior Quality Specialist

Job Description

The Senior Quality Assurance Specialist to play a vital role in ensuring the quality and compliance of our products business. The person in this position will collaborate with various departments, including manufacturing, R&D, and regulatory affairs, to review documentation, conduct/host audits, investigate deviations, lead projects, and help manage document lifecycles. Additionally, the Senior Quality Assurance Specialist will perform back-up quality control duties.

Position Qualifications (Education, Skills, Experience):

• Bachelor’s Degree in life sciences preferred
• 7+ years’ of quality assurance experience
• Experience conducting/hosting quality audits, inspections, and assessments
• Knowledge of quality tools/concepts and their application such as Document Control/Change Control, Deviations, Corrective/Preventive Action, Internal Audit, batch record review, statistical process control, etc.
• Strong understanding of GMP/ISO regulations and quality management systems required.
• Life sciences/pharmaceuticals/diagnostics industry experience required
• Working experience with eQMS, ERP systems and other information systems.

Key Responsibilities:

• Provide oversight of CAPAs and doc control for assigned group(s)
• Perform internal audits and provide support for external audits
• Review and respond to department inquiries
• Communicate quality needs and feasibility for product releases
• Provide oversight of equipment maintenance and calibration schedules
• Review and approve laboratory data, standard operating procedures (SOPs), specifications and other quality documentation for completeness, accuracy, and compliance with regulatory standards (e.g. FDA, GxP).
• Conduct audits and inspections to assess compliance with applicable regulations (e.g. FDA, GxP) and company procedures.
• Investigate deviations from established procedures and protocols and implement corrective and preventative actions (CAPA) to prevent recurrence/occurrence.
• Participate in the development, implementation, and maintenance of quality systems and procedures.
• Provide training and guidance to colleagues on quality procedures and best practices.
• Contribute to the development and maintenance of quality management systems (e.g., QMS).
• Participate in risk assessments and develop risk mitigation strategies.
• Manage and track corrective and preventive actions (CAPA) to ensure timely resolution of quality issues.
• Stay up to date on current GxP regulations and industry best practices.
• Participate in the development and implementation of quality improvement initiatives.
• Maintain a comprehensive understanding of relevant regulations and quality standards (e.g., FDA, USP, ICH).
• Review training record compliance and report and investigate any discrepancies or shortcomings.
• Provide guidance and training to manufacturing and lab personnel on quality procedures, documentation practices, and regulatory requirements.
• Participate in data analysis and reporting activities.
• Conduct internal audits and support external audits and Inspections.
• Perform internal and external quality assessments, including vendor audits and inspections, to ensure adherence to quality standards and contractual agreements.
• Maintain accurate and complete quality documentation, ensuring proper recordkeeping.