Analytical QC Analyst: In-Process Testing (Contract)

R&D Partners; Novato (CA); On-site; USD 71,635,000 - 85,962,000; Full time

Benefits offered by this job

Medical insurance

401k plan

Employee Assistance Program

Long-term disability

Weekly payroll

Online timecard approval

Job summary

R&D Partners is seeking a Quality Control Analyst in Novato, CA to perform analytical test methods on in-process intermediates and drug products, supporting manufacturing for clinical and commercial therapeutics. The role covers A280, Bradford, UV absorbance, enzyme activity, HPLC/UPLC and method validation.

This is a 12-month contract with on-site schedule Wednesday through Saturday 1:00pm-11:30pm PT, requiring minimal supervision and strong data handling and collaboration with QA teams.

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, and experience in Microsoft PowerPoint preferred.
• Familiarity with BINOCS or similar scheduling systems is preferred.
• Familiarity with SAP or similar enterprise systems 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.

Responsibilities

• Perform a wide variety of analytical assays, maintaining test sample throughput, monitoring lab supplies, preparing reagents, contributing to process and method validation studies, supporting investigations and equipment validation, and brainstorming further development or improvement ideas for procedures.
• 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.
• Provide input or assay support to the progression of test method validation, investigations, technical studies, and method transfer protocols.
• Follow SOPs, make appropriate decisions in daily activities with minimal intervention, and recognize deviations from routine practices.
• Accurately complete tasks on time to achieve lab goals, while limiting GMP/procedural errors and incorporating feedback.
• Share housekeeping tasks and ensure systems for laboratory maintenance are adequate for inspection readiness.
• Monitor and control laboratory supply and critical reagent inventories.
• Qualify as trainer for specified methods and provide training to less experienced staff.
• Communicate proactively about compliance risks and deviations, initiate investigation records within required timeframes.
• Attend team huddles and department meetings, generate ideas for lab 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.
• Demonstrate time management and prioritization of routine work.
• Interpret results against defined criteria and apply basic critical thinking to routine work.
• Evaluate results against trend, report and troubleshoot as needed, and participate in discussions.
• Communicate relevant information to appropriate audiences and attend necessary meetings.
• Maintain a positive attitude and volunteer when schedule permits.

Skills

Good documentation

Written and verbal communication

Microsoft Word and Excel

Quality management systems

Education

Bachelor of Science degree

Tools

BINOCS

SAP

Microsoft PowerPoint

Job description

R&D Partners is seeking a Quality Control Analyst in Novato, CA to perform analytical test methods on in-process intermediates and drug products, supporting manufacturing for clinical and commercial therapeutics. The role covers A280, Bradford, UV absorbance, enzyme activity, HPLC/UPLC and method validation.

This is a 12-month contract with on-site schedule Wednesday through Saturday 1:00pm-11:30pm PT, requiring minimal supervision and strong data handling and collaboration with QA teams.