Analyst, QC I

Who We Are

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

About Technical Operations

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.

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.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Fully On Site (4 days, 10hrs per day: Wednesday through Saturday 1pm to Midnight (swing shift) Currently 4-10 work hours, with 4 shifts: Sundays- Wed- Days/ Swings (7-6/1-11) and Wed-Sat - Days/ Swings with an overlap on Wednesdays. Seeking candidates who can be OPEN to being flexible in switching their shifts if necessary. Early notice would be provided in the event a switch becomes needed. RESPONSIBILITIES

• Timely facilitation of incoming sample receipt and accessioning flow, decipher batch
  
  
  

assignments across all assay types in accordance with agreed upon best practices.

• Execute microbiological and/or analytical methods to facilitate in-process testing under
  
  
  

applicable cGMP guidelines, as well as contribute to the prompt reporting of results to

meet the required timetables of internal customers.

• Perform environmental monitoring sampling and testing of facilities, equipment, and
  
  
  

utilities.

• Evaluate completed assay validity, calculate and summarize results, analyze data per
  
  
  

expected or specification ranges. Assist with the compilation and verification of trend

analysis reports.

• Perform and collaborate with co-workers to appropriately share general housekeeping
  
  
  

activity assignments, and ensure systems for laboratory maintenance are adequate for

creating a consistent state of inspection readiness.

• Assist with monitoring and the control of laboratory supply and critical reagent
  
  
  

inventories.

• Perform growth promotion of media and microbial identification testing.
• Qualify as trainer for specified methods, provide training to less experienced staff.
• Provide on call coverage to support oversight of QC laboratory equipment functionality.
• Exhibit proactive communication upon occurrence of compliance risks and deviations
  
  
  

from laboratory procedures, perform initiation of investigation records within required

timeframes.

• Provide input or assay support to the progression of test method validation,
  
  
  

investigations, technical studies, and method transfer protocols.

• Attend team huddles and department meetings, generate ideas for laboratory
  
  
  

infrastructure improvements and method optimization.

• Perform other responsibilities as deemed necessary.
  
  
  

SkillsQUALIFICATIONS

• Experience with quality management systems, current Good Manufacturing Practices,
  
  
  

and QC principles.

• Demonstrated working knowledge with respect to certified functional activities.
• Good documentation, written and verbal communication skills are essential.
• Must possess the ability to perform most tasks with minimal supervision.
• Computer literacy is required, proficiency with Microsoft Word and Excel is essential,
  
  
  

experience with Microsoft PowerPoint, Access, or Visio is desired.

• Must have a quality service attitude and focus, exhibit flexibility and willingness to work
  
  
  

Additional Hours To Meet Production Or Laboratory Process Requirements.EducationEDUCATION

• Bachelor of Science degree.
• 0-3 years of relevant laboratory experience; QC specific experience is preferred.