Quality Control Data Management AnalystLocation Novato, California Workstyle Open to Hybrid Apply
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 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.
BioMarin in Novato
In the United States, BioMarin operates a Biopharma Manufacturing Site in Novato California.
What makes working here unique? At BioMarin, we feel the intense tie between the work we do and the life-changing results it delivers. Our focus on rare disease gives us the rare opportunity to truly impact lives. As BioMarin employees, we’re here because we want to be here. We enjoy our work — and each other. Our people are smart. Unassuming. Collaborative. Curious. Interesting. In return, there is development, empowerment and total reward.
The Quality Control Data Management Analyst is responsible for the management of the GMP documentation and data in support of:
- Test and release of Bulk Drug Substance and Drug Product.
- Test of stability samples.
- Testing and support for critical reagents and reference standards.
- Contract Manufacturing Operations (CMO) testing.
- Product Complaints.
Key functions of the role include:
- Generation of Certificates of Analysis.
- Generation of LIMS sample reports.
- Preparation of test summaries.
- Preparation of stability tables.
- Fulfilling document requests to support QA partner and Regulatory needs.
- Updating Quarterly Stability Reports.
- Providing review support of manually generated Certificate of Analysis for regional needs.
- Coordinating with QA partners to obtain external CMO data.
- Entering data in ongoing stability tables.
- Troubleshooting errors/discrepancies in data found during compilation.
- Coordinating with lab owner to resolve discrepancies found during compilation.
- Compilation, filing, and archival of lot release, stability, and reference material data.
- Compilation and scanning test records to support needs of BioMarin Shanbally site.
- Maintaining an organized Quality Control document room.
- Maintaining an online database of stability tables.
- Maintaining a database for tracking offsite data storage.
- Collaborating with Quality Assurance Document Control (QADC) in management of data filed in the onsite site archive room and in the offsite storage facility.
- Preparing and organizing data files into boxes to send to offsite storage facility.
- Issuance of release documentation such as test summaries and Certificates of Analysis.
- Prepare summaries and reports as needed.
- Maintain the data management system and document storage areas in an inspection-ready state.
- Ensure traceability is established across documentation for project deliverables.
- Expected to recognize deviations from accepted practice.
- Collaborate with cross functional teams on key site and Global programs.
- Interface with other BioMarin departments (Regulatory Affairs, Quality Assurance, Quality Control Labs, etc.) and contractors as necessary.
- Interpret and appropriate apply applicable 21CFR and GxP requirements.
- College degree preferred.
- High school diploma/GED.
- 1+ years experience in related positions including QC, documentation, administration.
- Ability to work independently, managing projects and meeting established timelines.
- Ability to follow written instructions and to perform tasks with direct or minimal supervision.
- Well-developed organizational skills and attention to details.
- Strong documentation skills.
- Good written, verbal, and communication skills.
- Ability to collaborate within Quality and with external partners.
- Computer literacy is required; Experience with Microsoft Word and Excel.
- Experience with Laboratory Information Management systems (i.e., LIMS) is preferred.
- Familiarity with Veeva and learning management systems are preferred.
- Exposure to cGMP, quality systems, document control, quality control preferred.
- Not applicable
- Achieving Excellence
- Courage / Challenge
- Develop Self & Others
- GMP Acumen
- Critical Thinking & Evaluation
- Organisational Awareness
- Performance Management
PLEASE 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.
PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.
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.