Job Details

(CW) QC Quality Control Analytical In-Process

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 life‑threatening rare diseases, with a core focus on enzyme replacement therapies. BioMarin 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 the manufacturing suites of the Novato, CA production facility. It 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 a 4x10 shift schedule. Sunday‑Wednesday shifts may change due to business need. Typical shift times are Day (07:00‑18:00) and Swing (13:00‑00:00) on Wednesday‑Saturday. Pay rate up to $27 per hour.

The Quality Control Analytical In‑Process (QCA‑IP) Analyst is responsible for performing 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. Knowledge areas include protein determination by A280, Bradford, and UV absorbance; enzyme activity; HPLC/UPLC; and method validation.

Responsibilities

• Timely facilitation of incoming sample receipt and accessioning flow, deciphering 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 required timetables of internal customers.
• Evaluate completed assay validity, calculate and summarize results, analyze data per expected or specification ranges; assist with compilation and verification of trend analysis reports.
• Perform and collaborate with co‑workers to appropriately share general housekeeping activity assignments and ensure laboratory maintenance systems support inspection readiness.
• Assist with monitoring and controlling laboratory supply and critical reagent inventories.
• Qualify as trainer for specified methods, providing training to less experienced staff.
• Exhibit 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; experience with Microsoft PowerPoint 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. 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.