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Senior Quality Assurance Associate – Biotechnology Operations

Type Permanent

Salary €60,000 - €70,000

Location Limerick

Ref # 7819

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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.

Hi, we’re Barden.  We’re the Partner Led Talent Advisory & Recruitment Firm that puts Talent first. With practices across Accounting & Tax, Business Support, Financial Services, Legal, Life Sciences, Supply Chain, and Technology, we help build world-class teams for Ireland’s top companies and we help top Talent achieve their ambitions. Simple.

Apply now to this job

Working with Aidan’s team

Aidan Crowley leads a team of life sciences talent advisory and recruitment experts that work exclusively with life sciences professionals across Ireland. With a deep understanding of leading businesses, team structures and cultures, Aidan and his team go to great lengths to provide a consultative and supportive services to the talent they work with. Aidan and his team are where life sciences professionals go for advice before they start looking for a job.

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    Thank you for your application. One of our expert team will be in touch in due course. In the meantime please do continue to browse our open assignments or check out some of our expert Life Sciences insights in our resources area.

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