Contract QC In-Process Analyst — Onsite Swing Shift

BioMarin Pharmaceutical Inc.; Novato (CA); On-site; USD 70,000 - 100,000; Full time

Job summary

BioMarin Pharmaceutical Inc. is seeking a QC Analytical In-Process (QCA-IP) Analyst to perform analytical test methods on in-process intermediates and drug products under cGMP guidelines. The role supports manufacturing for clinical and commercial therapeutics with oversight from a contract arrangement.

The position requires a BS degree and 0–3 years of QC lab experience, with familiarity in HPLC/UPLC, protein assays, and data analysis. Onsite work in Novato, CA, with a 4-day swing shift.

Qualifications

• Bachelor of Science degree.
• 0-3 years of relevant laboratory experience; QC experience preferred.
• Familiar with quality management systems and cGMP principles.
• Experience with certified functional activities.
• Strong documentation and communication skills.
• Ability to work with minimal supervision.
• Proficient in Microsoft Word and Excel; PowerPoint preferred.
• Familiarity with BINOCS or SAP is preferred.
• Willingness to work additional hours to meet lab needs.
• Quality service attitude and flexibility.

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, as well as contribute to the prompt reporting of results to meet the required timetables of internal customers.
• 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.
• Qualify as trainer for specified methods, provide training to less experienced staff.
• 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.
• Identify areas to improve operational excellence by reducing non-value-added activities and increasing process efficiency.
• Perform other responsibilities as deemed necessary.

Skills

Quality mindset

Attention to detail

Strong communication

Time management

Education

Bachelor of Science degree

Tools

BINOCS

SAP

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

BioMarin Pharmaceutical Inc. is seeking a QC Analytical In-Process (QCA-IP) Analyst to perform analytical test methods on in-process intermediates and drug products under cGMP guidelines. The role supports manufacturing for clinical and commercial therapeutics with oversight from a contract arrangement.

The position requires a BS degree and 0–3 years of QC lab experience, with familiarity in HPLC/UPLC, protein assays, and data analysis. Onsite work in Novato, CA, with a 4-day swing shift.