QA Specialist, External Quality (TEMPORARY)

at  Biomarin

Who We Are
For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more.
And the more people we reach, the more our impact can grow. We transform lives through genetic discovery.
Our Culture
Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard – so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients.
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.

SUMMARY

The Quality Assurance Specialist reports to the External Quality Manager, and is responsible for supporting quality systems, assisting with the batch release process of drug product and pack label finished goods orders produced by external Contract Manufacturing Organizations.

EDUCATION

Bachelor of Sciences (BSc) degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.

EXPERIENCE/SKILLS

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.
Ability to comprehend technical information related to equipment, manufacturing processes, and regulatory expectations.
Experience with participation in regulatory inspections is desirable.
Ability to speak, present data, and defend approaches in front of audiences and inspectors.
Understanding and familiarity with FDA & European regulatory requirements, guidelines, and expectations.
Excellent interpersonal skills with the ability to work as part of a dynamic team and efficiently engage both interdepartmentally and with external CMO’s.
Excellent written and verbal communication skills.
Strong organizational skills, including ability to follow assignments through to completion.
Proficiency in PC skills such as Excel, Word, PowerPoint.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law

RESPONSIBILITIES

• Assist with quality oversight of the supply chain, manufacture, and packaging of products in various Contact Manufacturing Organizations.
• Review of Manufacturing/Packaging batch records as applicable and relevant Quality Control documentation prior to recommending final batch release.
• Review and approve standard operating procedures, master batch records and product specifications.
• Provide Quality oversight of Deviation and Investigation reports to ensure that root causes have been identified and appropriate corrective actions have been implemented.
• Provide Quality oversight of Change Controls ensuring scope of record is clear and implementation activities are robust and timely.
• Proactively support the continuous improvement of quality systems by identifying and building in efficiencies from a systematic and compliance perspective.
• Assist with periodic audits and reviews of contract manufacturers to ensure compliance with cGMPs and other regulatory requirements.
• Assist with regulatory requests and inspections, both internal and external.
• Assist with new market launches.
• Review temptale data and prepare CCFP to forward process.
• Prepare lot files to support batch release.
• Updates to relevant quality technical agreements as needed.
• Support external customer complaints as required.