BIOMARIN
(CW) QC Quality Control Analytical In-Process (TEMPORARY)
BIOMARIN, Novato, California, United States, 94949
Who We Are
BioMarin Pharmaceutical Inc. is a company founded in 1997 and based in San Rafael, CA that specializes in the development of therapeutics for serious and often times life-threatening rare diseases, in which a core component of products is enzyme replacement therapies. To date, it has become the first company to commercialize treatments for types of mucopolysaccharidosis (MPS) and phenylketonuria (PKU). The Quality Control Process Monitoring group is a laboratory that works in tandem with Manufacturing suites of the Novato, CA production facility which evaluates how well all major stages meet respective characteristic and performance parameters to ensure consistency and quality of each final product line. This is a contract role with shift 4x10. Shifts are Sunday-Wednesday (Day 0700-1800 or Swing 1300-0000) or Wednesday-Saturday (Day 0700-1800 or Swing 1300-0000). Pay rate up to $27 per hour. 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 analytical methods to facilitate in-process testing under applicable cGMP guidelines, and contribute to prompt reporting of results to meet internal customer timetables. 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 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 control of laboratory supply and critical reagent inventories. Qualify as trainer for specified methods, provide training to less experienced staff. Exercise proactive communication upon occurrence of compliance risks and deviations from laboratory procedures; initiate 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. Qualifications
Bachelor of Science degree. 0-3 years of relevant laboratory experience; QC specific experience is preferred. 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, with proficiency in Microsoft Word and Excel; Microsoft PowerPoint experience is preferred. Must have a quality service attitude and focus, exhibit flexibility and willingness to work additional hours to meet production or laboratory process requirements. 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. In the U.S., the salary range for this position is $15 to $30 per hour. The base pay actually offered will take into account internal equity and may vary depending on geographic region, job-related knowledge, skills, and experience. This position may be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans. For additional benefits information, visit: https://careers.biomarin.com/benefits. Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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BioMarin Pharmaceutical Inc. is a company founded in 1997 and based in San Rafael, CA that specializes in the development of therapeutics for serious and often times life-threatening rare diseases, in which a core component of products is enzyme replacement therapies. To date, it has become the first company to commercialize treatments for types of mucopolysaccharidosis (MPS) and phenylketonuria (PKU). The Quality Control Process Monitoring group is a laboratory that works in tandem with Manufacturing suites of the Novato, CA production facility which evaluates how well all major stages meet respective characteristic and performance parameters to ensure consistency and quality of each final product line. This is a contract role with shift 4x10. Shifts are Sunday-Wednesday (Day 0700-1800 or Swing 1300-0000) or Wednesday-Saturday (Day 0700-1800 or Swing 1300-0000). Pay rate up to $27 per hour. 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 analytical methods to facilitate in-process testing under applicable cGMP guidelines, and contribute to prompt reporting of results to meet internal customer timetables. 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 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 control of laboratory supply and critical reagent inventories. Qualify as trainer for specified methods, provide training to less experienced staff. Exercise proactive communication upon occurrence of compliance risks and deviations from laboratory procedures; initiate 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. Qualifications
Bachelor of Science degree. 0-3 years of relevant laboratory experience; QC specific experience is preferred. 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, with proficiency in Microsoft Word and Excel; Microsoft PowerPoint experience is preferred. Must have a quality service attitude and focus, exhibit flexibility and willingness to work additional hours to meet production or laboratory process requirements. 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. In the U.S., the salary range for this position is $15 to $30 per hour. The base pay actually offered will take into account internal equity and may vary depending on geographic region, job-related knowledge, skills, and experience. This position may be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans. For additional benefits information, visit: https://careers.biomarin.com/benefits. Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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