In-Process QC Analyst: Drive Method Validation & Data Insights

TALENT Software Services; Novato (CA); On-site; USD 65,000 - 85,000; Full time

Job summary

TALENT Software Services is seeking a Quality Control Analytical In-Process (QCA-IP) Analyst to perform analytical test methods on in-process intermediates and various drug product stages under minimal supervision and cGMP guidelines. This role will involve knowledge including protein determination by A280, Bradford, UV absorbance, enzyme activity, HPLC/UPLC, and method validation.

You will support manufacturing for clinical and commercial therapeutics, interpret results, contribute to trend

Qualifications

• Bachelor of Science degree.
• 0-3 years of relevant laboratory experience; QC experience preferred.
• Experience with quality management systems and GMP.
• Good documentation and communication skills.
• Ability to work with minimal supervision.
• Proficiency in Word and Excel; PowerPoint preferred.
• Familiarity with scheduling systems (BINOCS) and SAP preferred.
• Willingness to work additional hours to meet production needs.

Responsibilities

• Timely facilitation of incoming sample receipt and accessioning flow.
• Execute analytical methods for in-process testing under cGMP guidelines.
• Evaluate assay validity, summarize results, analyze data, and assist with trend analysis.
• Share general housekeeping tasks and maintain inspection readiness.
• Monitor and control laboratory reagent inventories.
• Qualify as trainer for specified methods and train less experienced staff.
• Communicate compliance risks and initiate investigations when needed.
• Support method validation, investigations, and transfer protocols.
• Attend team meetings and suggest lab infrastructure improvements.
• Identify opportunities to improve operational efficiency.
• Perform other responsibilities as deemed necessary.

Education

Bachelor of Science degree

Tools

Excel

BINOCS

SAP

Job description

TALENT Software Services is seeking a Quality Control Analytical In-Process (QCA-IP) Analyst to perform analytical test methods on in-process intermediates and various drug product stages under minimal supervision and cGMP guidelines. This role will involve knowledge including protein determination by A280, Bradford, UV absorbance, enzyme activity, HPLC/UPLC, and method validation.

You will support manufacturing for clinical and commercial therapeutics, interpret results, contribute to trend