Senior Quality Assurance Specialist

About Discovery Life Sciences:

Key Responsibilities:

• Review and approve batch records, 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.
• 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

• 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.
• Maintain accurate and complete quality documentation, ensuring proper recordkeeping.
• Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.
• Consistent and predictable attendance is an essential function of the position.
• 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.
• Provides progress reports to the direct supervisor.

Qualifications / Experience:

• Bachelor's/Master’s degree in a science discipline (e.g., biology, chemistry, engineering) preferred.
• Minimum 7 years’ experience in a Quality Assurance/Quality Control role in Manufacturing or Life Sciences Previous biotech/pharma or medical devices experience preferred.
• Strong understanding of GxP/ISO regulations and quality management systems.
• Experience conducting quality audits, inspections, and assessments
• 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.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).
• 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.
• Working experience with eQMS, ERP systems and other information systems.

Compensation and Benefits:

Location and work hours:

• This position Is on site at our office in Sofia, Bulgaria.