QA Associate

Location:  Cork, Ireland Category: Quality


Who We Are

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

QA Associate - Shanbally, Ringaskiddy, Cork (Shift Work) 
This position within the QA department provides Quality oversight, support and knowledge to activities relating to Quality to meet BioMarin business priorities. The QA Associate will have proven capability in promoting Quality across cross-functional teams, to deliver high quality product, ensuring continuous process improvement. The QA Associate will model the BioMarin Leadership behaviours and understand the principles to drive a culture of continuous improvement building a High-Performance Organisation. 
General QA Associate Responsibilities:
  • Provide Quality input and guidance to ensure Lot Release (Final Packed Finished Product) of high-quality products in compliance with current Good Manufacturing Practices (GMPs).
  • Compilation of Lot Release Packs as per requirements of SOPs, WIs and related FRMs.
  • Support for the Secondary Packaging Operations team including performance of AQL inspections during routine operations.
  • Provide Quality direction and oversight of the development and continuous improvement of new and existing processes / systems to meet customer needs.
  • Exercise judgment to determine appropriate action, ensuring proper escalation when non-conformances are identified as per applicable procedures for compliance, escalation and corrections.
  • Provide Quality input to Change Control/Deviations ensuring scope of record is clear and implementation activities are robust and timely. Review and approval of Deviations and associated CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable.
  • Participates within inter-departmental and cross-functional teams, with direct interface with Manufacturing, Supply & Distribution, Maintenance, Metrology and Quality Control employees to immediately address issues and questions in real time to help ensure timeline are achieved to meet customer requirements. Minimising impact to Lot Release operations on site.
  • Prioritizes tasks to ensure the critical tasks are completed on time and meet requirements.
  • Review and release inputs for use in manufacturing as required.
  • Write, review and approve Standard Operating Procedures in accordance with BioMarin Policies. 
  • Assignments may range from routine to more complex/non-routine projects/assignments, where analysis of situation or data requires a review of identifiable factors within the Lot Release operations area.
  • Coordinates, plans, implements projects within specified objectives 
  • Prioritizes tasks to ensure the critical tasks are completed on time and meet requirements. 
  • Reviews executed packaging batch records and associated documentation.
  • Participates in customer complaint investigations if required. 
  • Provides training and advice to staff in order for them to perform their desired functions.
  • Participation in and leading internal inspections in the Lot Release area of operations.
  • Prepare reports for Product Quality Reviews including batch listing and deviation trend reports to ensure that trends are acted upon and to demonstrate that products consistently meet desired critical quality attributes.
  • Degree or 3rd level qualification (Science, Quality).
  • Demonstrated experience in Lot Release and Secondary Packaging as the Quality contact for the area.
  • Relevant experience (5yrs +) working in a Quality function in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the other requirements of the role.
  • Demonstrates good knowledge of FDA / EMEA regulations/standards and quality systems.
  • Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance.
  • Demonstrated ability to work and succeed within teams as well as leading small project teams while maintaining and strengthening trust relationships with people on all levels.
  • Strong organizational skills, including ability to follow assignments through to completion.
  • Proficiency in PC skills such as Excel, Word, PowerPoint.
  • Proven decision-making capability with full accountability and responsibility.
  • Demonstrated coaching skills.
  • Excellent written and verbal communication skills.
  • Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non-Conformance /Deviation investigations.
  • Lot Release experience in the area of Drug Substance, Secondary and Final Packed Drug Product.
  • Experience in lot release of device and combination packaged products.
  • Experience in execution, documentation and follow-up of in-process inspections for Secondary Packaging processes.
  • Evidence of Continuous Professional Development.
  • Evidence of Validation knowledge/experience.
  • MES experience.
  • Good knowledge of Lean / Continuous Improvement practices and root cause analysis.
  • Always focused on the patient and customer needs.
  • Resilient profile with the ability to deliver in a challenging environment.
  • Ability to engage and manage multiple stakeholders to achieve the objective.
  • Curious with learning agility.
  • Operationally excellent, with attention to detail.
  • Organised with systematic approach to prioritisation.
  • Process orientated to achieve the business objective

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.