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Analyst, QC In-Process

Location Novato, California
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 kind.

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.

PURPOSE
The QC In-Process (QCIP) Analyst is responsible for performing microbiological and analytical test methods on in-process intermediates and varying stages of drug products, under minimal supervision and within cGMP guidelines, to support further manufacturing of commercial and clinical therapeutics. This role will involve knowledge that includes but is not limited to the following analyses and concepts: Protein determination by BCA, Bradford, and UV Absorbance, Enzyme activity, Endotoxin detection, Bioburden quantification, HPLC, Total Organic Carbon, microbial identification and challenge studies, aseptic techniques, and method validation.

CHARACTERISTICS
Functional activities may include: performing a wide variety of microbiological and/or analytical assays, maintaining test sample throughput, monitoring lab supplies, preparing reagents, contributing to process and method validation studies, supporting investigations and equipment validation, and brainstorm further development or improvement ideas for procedures.

Work assignments will vary by degree of complexity. Employee is expected to follow SOPs, make appropriate decisions in daily activities with minimal needs for intervention, and be able to recognize deviations from routine practices. Incumbent must accurately complete tasks on time to achieve lab goals, meanwhile limiting GMP / procedural errors, and be capable of accepting and incorporating feedback. Must also demonstrate the ability to both manage time and prioritize routine work effectively.

Employee must be able to interpret results against defined criteria, begin to apply critical thinking to routine work. He/she should demonstrate an ability to evaluate results against trend reports, serve some degree of troubleshooting and capacity as trainer, and embrace an active role in following up on atypical results or issues.

Communication of relevant information must be made to appropriate audiences, and attendance of necessary team meetings with some participation in discussions is essential. Employee should also be actively engaged in his/her role, exhibit frequent volunteerism as the work schedule flow permits, and maintain a positive attitude.

RESPONSIBILITIES
1. Timely facilitation of incoming sample receipt and accessioning flow, decipher batch assignments across all assay types in accordance with agreed upon best practices.
2. 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.
3. 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.
4. 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.
5. Assist with monitoring and the control of laboratory supply and critical reagent inventories.
6. Qualify as trainer for specified methods, provide training to less experienced staff.
7. Provide on call coverage to support oversight of QC laboratory equipment functionality.
8. Exhibit proactive communication upon occurrence of compliance risks and deviations from laboratory procedures, perform initiation of investigation records within required timeframes.
9. Provide input or assay support to the progression of test method validation, investigations, technical studies, and method transfer protocols. 10. Attend team huddles and department meetings, generate ideas for laboratory infrastructure improvements and method optimization.
11. Perform other responsibilities as deemed necessary.

QUALIFICATIONS
1. Bachelor of Science degree.
2. 0-3 years of relevant laboratory experience; QC specific experience is preferred.
3. Experience with quality management systems, current Good Manufacturing Practices, and QC principles.
4. Demonstrated working knowledge with respect to certified functional activities.
5. Good documentation, written and verbal communication skills are essential.
6. Must possess the ability to perform most tasks with minimal supervision.
7. Computer literacy is required, proficiency with Microsoft Word and Excel is essential, experience with Microsoft PowerPoint, Access, or Visio is desired.
8. Must have a quality service attitude and focus, exhibit flexibility and willingness to work additional hours to meet production or laboratory process requirements.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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Novato

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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