In-Process QC Analyst: Analytical Methods & Validation

Planet Pharma; Novato (CA); On-site; USD 52,000 - 62,000; Full time

Job summary

Planet Pharma seeks a Quality Control Analytical In-Process (QCA-IP) Analyst to perform analytical tests on in-process intermediates and various drug products under cGMP guidelines. You will handle methods like A280, Bradford, UV, HPLC/UPLC, and method validation with minimal supervision.

Role requires 0–3 years of QC lab experience, strong documentation, and proficiency with MS Office; familiarity with SAP or similar systems is a plus.

Qualifications

• Bachelor of Science degree required.
• 0–3 years of lab experience; QC experience preferred.
• Knowledge of cGMP and Quality Management Systems.
• Strong documentation and communication skills.
• Proficiency in MS Word/Excel; familiarity with SAP or similar systems.

Responsibilities

• Timely processing of incoming samples and accessioning across assay types.
• Execute analytical methods for in-process testing under cGMP guidelines and report results promptly.
• Evaluate assay validity, summarize results, and assist with trend analyses.
• Share housekeeping duties and maintain lab systems for inspection readiness.
• Monitor inventories of laboratory supplies and reagents.
• Train less-experienced staff on specified methods.
• Communicate compliance risks and deviations; initiate investigations when needed.
• Support method validation, investigations, and transfer protocols.
• Attend team meetings and contribute ideas for lab improvements.
• Identify opportunities to improve efficiency and reduce non-value-added steps.
• Perform other duties as required.

Skills

Attention to detail

Documentation

Communication

Time management

Self-motivated

Education

Bachelor of Science

Tools

SAP

BINOCS

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

Planet Pharma seeks a Quality Control Analytical In-Process (QCA-IP) Analyst to perform analytical tests on in-process intermediates and various drug products under cGMP guidelines. You will handle methods like A280, Bradford, UV, HPLC/UPLC, and method validation with minimal supervision.

Role requires 0–3 years of QC lab experience, strong documentation, and proficiency with MS Office; familiarity with SAP or similar systems is a plus.