Quality Assurance Packaging Specialist.
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
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. Come join our team and make a meaningful impact on patients’ lives.
This position within the QA department provides Quality oversight, support and knowledge to activities relating to Quality to meet BioMarin business priorities. The Quality Packaging Specialist will have proven capability in promoting Quality across cross-functional teams, to deliver high quality product, ensuring continuous process improvement. The Quality Packaging Specialist will model the BioMarin Leadership behaviors and understand the principles to drive a culture of continuous improvement building a High Performance Organisation. General QA Specialist Responsibilities:
- Provide Quality input and guidance to ensure packaging of high quality products in compliance with current Good Manufacturing Practices (GMPs).
- Provide Quality direction and oversight of the development of new and existing processes in the packaging area 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 within the packaging area of operations.
- Provide Quality input to Change Control/Deviations ensuring scope of record is clear and implementation activities are robust and timely. Review and approval of NCs 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 packaging 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 packaging 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 packaging 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.
- Normally receives very little instruction on routine work, general instructions on new assignments
QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS
- Degree or 3rd level qualification (Science, Quality).
- Demonstrated experience in 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
- Packaging QA function, with experience in blister seal operations
- Evidence of Continuous Professional Development.
- Evidence of Validation knowledge/experience
- MES experience.
- Good knowledge of Lean 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
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.