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 coordinate the worldwide movement of our drugs to patients.
QA Associate (Temporary) - Shanbally, Ringaskiddy, Cork (Shift Work)
Closing Date: 30th May
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, delivering high-quality products, and ensuring continuous process improvement. The QA Associate will model BioMarin Leadership behaviors and understand the principles to drive a culture of continuous improvement, building a High-Performance Organization.
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).
* Compile Lot Release Packs as per SOPs, WIs, and related FRMs.
* Support the Secondary Packaging Operations team, including performing AQL inspections during routine operations.
* Provide Quality direction and oversight for the development and continuous improvement of processes/systems to meet customer needs.
* Exercise judgment to determine appropriate actions, ensuring proper escalation when non-conformances are identified, following applicable procedures for compliance, escalation, and corrections.
* Support Change Control/Deviations processes, including review and approval of Deviations and CAPAs, ensuring compliance and root cause resolution.
* Collaborate with Manufacturing, Supply & Distribution, Maintenance, Metrology, and Quality Control teams to address issues in real-time, minimizing impact on Lot Release operations.
* Prioritize tasks to ensure critical activities are completed on time.
* Review and release inputs for manufacturing as required.
* Write, review, and approve SOPs according to BioMarin policies.
* Manage routine to complex projects, analyzing situations within the Lot Release area.
* Coordinate and implement projects within set objectives.
* Review packaging batch records and related documentation.
* Participate in customer complaint investigations if required.
* Provide training and guidance to staff.
* Lead internal inspections in the Lot Release area.
* Prepare reports for Product Quality Reviews, including batch listing and deviation trend reports.
Qualifications & Experience - Knowledge And Skills Requirements
REQUIRED:
* Degree or 3rd level qualification in Science, Quality, or related field.
* Experience in Lot Release and Secondary Packaging as the Quality contact.
* Over 5 years of relevant experience in a pharmaceutical or biotech Quality function.
* Knowledge of FDA/EMEA regulations and quality systems.
* Ability to work independently and lead improvement initiatives.
* Strong teamwork and leadership skills, with trust-building abilities.
* Excellent organizational skills and PC proficiency (Excel, Word, PowerPoint).
* Decision-making skills with accountability.
* Coaching and communication skills.
* Experience in problem-solving, Root Cause Analysis, Non-Conformance, and Deviations.
DESIRED:
* Experience in Drug Substance, Final Packaged Drug Product, or Device Lot Release.
* Experience with in-process inspections for Secondary Packaging.
* Continuous Professional Development evidence.
* Validation knowledge and MES experience.
* Knowledge of Lean/Continuous Improvement practices.
BEHAVIOURS:
* Patient and customer-focused.
* Resilient and adaptable in challenging environments.
* Stakeholder engagement skills.
* Curious and eager to learn.
* Operational excellence with attention to detail.
* Organized with systematic prioritization.
* Process-oriented to achieve business objectives.
An Equal Opportunity Employer. All qualified applicants will receive consideration regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability.
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