Barden are delighted to be supporting our Global Biopharmaceutical client in their search for a Senior Quality Assurance Associate – Biotechnology Operations for their state-of-the-art start up biotech manufacturing campus in Limerick.
ABOUT THE ROLE:
The Senior Quality Assurance Associate – Biotechnology Operations will play a critical role in maintaining the quality and regulatory compliance of their biopharmaceutical products within their next-generation manufacturing facility. You will also work closely with cross-functional teams to implement and uphold quality assurance standards, facilitate inspections and audits, and support continuous improvement initiatives.
Roles & Responsibilities:
- Develop and maintain quality assurance procedures, policies, and systems.
- Conduct routine self-inspections and monitoring assessments (time-on-the-floor) to ensure compliance with cGMP (current Good Manufacturing Practices) and other relevant regulations.
- Collaborate with production and QC teams to ensure product quality throughout the manufacturing process.
- Investigate and address deviations, non-conformities, and CAPA (Corrective and Preventive Actions) to maintain product quality.
- Stay current with industry regulations, guidelines, and best practices.
- Assist in the preparation and execution of regulatory inspections and audits.
- Ensure that all products meet regulatory requirements, including documentation and reporting.
- Maintain accurate and comprehensive quality records, including batch records, change control documentation, and quality reports.
- Prepare and review documentation related to product quality and compliance including GMP standard operating procedures, process flow documents as well as equipment qualification and process validation documentation.
- Perform batch disposition, including approval of drug substance batch records and associated CoA’s.
- Identify areas for process improvement and work collaboratively with cross-functional process teams to implement changes.
- Participate in risk assessments and quality improvement projects.
- Provide training to staff on quality-related procedures and best practices.
- Stay informed about the latest developments in biotechnology and quality assurance.
ABOUT THE PERSON:
Education & Work Experience:
- Minimum of 5 years of experience in quality assurance within a biotechnology or pharmaceutical manufacturing environment.
- Strong knowledge of cGMP, FDA, Data Integrity, Quality Risk Management and other biopharmaceutical regulatory requirements.
- Excellent problem-solving and analytical skills.
- Detail-oriented with a strong commitment to maintaining high-quality standards.
- Effective communication and teamwork skills.
- Demonstrated initiative – able to work proactively without direct supervision and with a continuous improvement mind-set.
- Experience with quality management systems (e.g., TrackWise, MES) is a plus.
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