In-Process QC Analyst: Analytical Methods

TALENT Software Services; Novato (CA); On-site; USD 60,000 - 90,000; Full time

Job summary

TALENT Software Services seeks a Quality Control Analytical In-Process (QCA-IP) Analyst in Novato, CA to perform analytical tests on in-process intermediates and drug products under cGMP guidelines, including A280, Bradford, UV absorbance, enzyme activity, HPLC/UPLC, and method validation. Work follows SOPs with minimal supervision, ensuring timely results, data integrity, and compliance.

Responsibilities include report generation, trend analysis, training staff, and supporting method

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

• Timely reception and accessioning of incoming samples.
• Execute analytical methods for in-process testing under cGMP guidelines.
• Evaluate completed assay results and summarize data; assist with trend analyses.
• Maintain housekeeping and readiness of lab systems and equipment.
• Monitor laboratory inventories of reagents and supplies.
• Qualify as trainer and provide training to less experienced staff.
• Communicate risks and deviations, initiate investigations when required.
• Support method validation, investigations, and transfer protocols.
• Attend team meetings and contribute to lab improvements.
• Identify opportunities to improve process efficiency and reduce non-value-added activities.
• Perform other duties as needed.

Skills

Documentation

Verbal communication

Written communication

Attention to detail

Self-motivation

Education

Bachelor of Science degree

Tools

BINOCS

SAP

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

TALENT Software Services seeks a Quality Control Analytical In-Process (QCA-IP) Analyst in Novato, CA to perform analytical tests on in-process intermediates and drug products under cGMP guidelines, including A280, Bradford, UV absorbance, enzyme activity, HPLC/UPLC, and method validation. Work follows SOPs with minimal supervision, ensuring timely results, data integrity, and compliance.

Responsibilities include report generation, trend analysis, training staff, and supporting method