QA Associate

Who We Are
BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.
Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.
Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.
About Worldwide Research and Development
From research and discovery to post-market clinical development, our R&D engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases.

Title: QA Associate

Work type: Contract (Shift role)

Duration: 12 Months

Pattern: 3 days, 3 nights, 2 days, 2 nights

Mon to Fri – 6am to 6pm, 6pm to 6am

SUMMARY DESCRIPTION

BioMarin is a high-performing, team-based organisation, where colleagues are flexible, multi-skilled and empowered to make decisions. A high level of initiative, energy and motivation are key requirements, as well as excellent organisational skills.

As part of establishing sterile filling operations at the Shanbally facility, this role (which reports to the QA Operations Manager) will provide QA support for the start-up of the facility, before moving into routine QA support of the same.

The successful candidate will also have proven capability in promoting Quality across cross-functional teams, to deliver on-time, high-quality processes and products, whilst ensuring continuous process improvement.

NOTE: THIS IS A SHIFT ROLE

Key Responsibilities: 

• Provide Quality direction and oversight of the start-up, technical transfer, operation, and continuous improvement of Sterile Drug Product Filling operations.  
• Provide Quality input to Change Controls, Protocols and Reports ensuring scope of records are clear and implementation activities are robust and timely.
• Write, review and approve Standard Operating Procedures, Work Instructions, Quality Technical Agreements, Master Batch Records, Specifications and other GMP documentation in accordance with BioMarin Policies. 
• Participates within inter-departmental and cross-functional project teams to immediately address issues and questions in real time to help ensure project timelines are achieved.
• Prioritizes tasks to ensure the critical tasks are completed on time and meet requirements.
• Provide Quality input and guidance to ensure Lot Release (Components/Raw Materials/Drug 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.
• Provide Quality input to 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.
• Exercise judgment to determine appropriate action, ensuring proper escalation when issues are identified as per applicable procedures for compliance, escalation and corrections.
• Pro-actively identifies compliance risks and takes appropriate preventative actions.  
• Proactively identify potential issues, lead root cause analysis, make recommendations and aid in implementation for more complex and non-reoccurring issues. 
• Ensure high level of Quality / cGMP Awareness in the Project Team and Sterile Filling Team.
• Lead Area GMP Certification Activities.
• Support pre-approval Regulatory Inspection readiness to ensure regulatory approvals are obtained. 
• Support all Quality Assurance elements needed to facilitate new product launches. 

QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS 

REQUIRED: 

• Degree or 3rd level qualification (Science, Quality). QP Qualification would be an advantage.
• Demonstrated experience in Sterile Drug Product Filling and start-up of same.
• 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.

DESIRED: 

• Experience in Sterile Drug Product Filling and start-up of same.
• Evidence of Continuous Professional Development.
• Evidence of Validation knowledge/experience.
• MES experience.
• Good knowledge of Lean / Continuous Improvement practices and root cause analysis.

BEHAVIOURS: 

• 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.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. 
Equal Opportunity Employer/Veterans/Disabled
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.
Ireland Safety Responsibility
Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.