External Quality Associate I
Company: BioMarin Pharmaceutical Inc.
Posted on: May 14, 2022
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
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
We are a high-performing, team-based organization, where colleagues
are flexible, multi-skilled and empowered to make decisions.A
high-level of initiative, energy, and motivation are key role
requirements, as well as organizational skills and the ability to
motivate others.The External Quality Associate 1 reports to the
External Quality Manager and is responsible for supporting Quality
Systems related to operations, product specification change
controls and batch release processes. This position requires
interaction with multiple levels in Quality, Regulatory Affairs,
Manufacturing, Supply Chain, Materials Management, and Contract
Manufacturing Operations.KEY RESPONSIBILITIES
- Create and/or revise product specification documents, following
MAA, BLA, CTA, IND and/or IMPD filings, in BioMarin's controlled
document management system (Veeva).
- Initiate and set-up change control workflows for product
specification revisions in Veeva and BioMarin's quality management
- Coordinate TrackWise and Veeva change control workflows for
review and approval of product specification revisions.
- Monitor and ensure document implementation timelines.
- Monitor backlog in associated trackers.
- Generate custom Certificates of Analysis to support lot
release, new market applications, annual product reviews, and/or
- Ensure all individual training and group-specific guidelines
are kept current.
- Provide assistance with training new staff.EXPERIENCE
- Minimum 3-5 years of experience in a Quality, Compliance,
and/or Regulatory setting.
- Strong attention to detail, organization and communication
- Ability to maintain organization of a large volume of data in a
- Proficiency with computer systems (Microsoft Office
- Proficiency with eQMS (TrackWise), LIMS, Oracle EBS, eCDMS
(Veeva) and Office365 preferred.
PLEASE NOTE: Absent a Medical or Religious reason that prohibits
vaccinations, all our incoming employees must be vaccinated for
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.
Keywords: BioMarin Pharmaceutical Inc., Novato , External Quality Associate I, Other , Novato, California
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