About Discovery Life Sciences:
Discovery Life Sciences (DLS) is a leading provider of highly characterized human biospecimens and cellular starting materials to advance cell and gene therapy and precision medicine programs for cancer, infectious disease, and other complex conditions. We routinely manage hundreds of studies and expertly test thousands of biospecimens simultaneously. Leading biopharma, diagnostic and academic institutions trust us to quickly deliver high-quality biospecimens and reliable, reproducible biomarker data, so they can outpace their competition and push the leading edge of innovation using our Science at your Service TM business model.
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:
Discovery Life Sciences is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's qualifications, skills, and experience.
Location and work hours:
- This position Is on site at our office in Sofia, Bulgaria.
