Specialist/Sr. Specialist Document Control
BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development 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. Come join our team and make a meaningful impact on patients’ lives.
The position is responsible for actively supporting the quality and management of Controlled Documents (including Standard Operating Procedures, Work Instructions, Forms, Templates) for the Worldwide Research and Development (WWRD) Quality. This position will also have general administrator responsibilities in working with the Electronic Document Management System (EDMS). She/He will be responsible for document management and support as a Specialist/Senior Specialist in WWRD Quality.
The candidate will provide hands-on expertise in supporting the documentation of procedures and processes to ensure quality standards are robust and meet global regulatory requirements, company standards and quality goals.
- Strong working knowledge of GCPs and GLPs and the drug development lifecycle with experience in developing quality review and control of processes, managing documents through an EDMS across Clinical Development, R & D and/or drug development.
- Support the WWRD Quality Management System which include performing activities within the EDMS and understanding critical interfaces of the systems comprising the QMS (including but not limited to the LMS and CAPA/Deviation tracking system.)
- Perform quality control reviews, edits and formats, of controlled documents and written procedures against internal standards
- Ensure that information on WWRD Controlled Documentations (including inventory and relationship management) is maintained
- Monitor the EDMS to collect assignments, and support internal client functions (i.e. document owner, author, initiator) in processing and moving controlled documents through workflows established in the EDMS
- Track and trend workflow activities in the EDMS to troubleshoot issues and identify areas for improvement
- Provide internal support to the Quality Standards and Training group on administrative tasks related to internal procedures (e.g. managing folders in Livelink, supporting internal webpage maintenance).
- Serve as a backup in meetings that are related to controlled documents or EDMS
- Participate in the development and continuous improvement of WWRD Quality processes, systems, and written procedures as instructed
- Provide support and direction to develop and maintain a Quality Management System to recognized industry standards.
- Partner with stakeholders across the organization to address compliance issues related to quality systems and/or processes.
- Able to work under limited supervision.
- Solid communication, interpersonal, and collaborative stills.
- Ability to adapt and work in a fast-paced, dynamic environment.
- Ability to prioritize activities and assignments.
- Clear focus on quality and attention to detail in process documents.
- Process mapping and process development skills desired.
Bachelors’ Degree (BA/BS), from an accredited college or university or commensurate work experience.
- 1-3 years of experience working with computerized systems in a Quality Assurance setting
- Experience working in the biotech/pharmaceutical industry specifically in the area of quality assurance area is preferred
- Strong working knowledge of regulatory regulations and guidelines include FDA, ICH, and EMA. (Both GCP and GLP experience preferred).
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.