QC Analyst I

QC Analyst I
Pay Rate: $30/hour
Duration: 1-year contract with potential to extend or convert
Location: 100% onsite inNovato, CA
Schedule: Swing Shift 4-days/week WED - SAT 1PM - 11:30PM

We are seeking a QC Analyst to join the In-Process Analytical (QCA-IP) laboratory. This individual will perform analytical testing on manufacturing intermediates and drug products while ensuring compliance with cGMP regulations. The ideal candidate has a strong laboratory foundation, excellent documentation skills, and experience working in a regulated pharmaceutical, biotech, or life sciences environment.

Key Responsibilities

• Perform analytical testing on in-process manufacturing samples using established methods.
• Execute protein assays including A280, Bradford, UV Absorbance, enzyme activity assays, and HPLC/UPLC.
• Analyze and interpret data against specifications and trending requirements.
• Document laboratory activities in accordance with cGMP and GDP requirements.
• Prepare reagents, maintain laboratory supplies, and support laboratory organization.
• Assist with method validation, method transfers, equipment qualification, and technical investigations.
• Participate in deviation investigations and support continuous process improvements.
• Maintain laboratory inspection readiness and assist with housekeeping activities.
• Train junior analysts on qualified laboratory methods as appropriate.
• Collaborate closely with Manufacturing, Quality Assurance, and other cross-functional teams to ensure timely sample testing.

Qualifications

• Bachelor's degree in Biology, Chemistry, Biochemistry, Molecular Biology, or a related scientific discipline.
• 0 3 years of laboratory experience (QC experience preferred).
• Experience working under cGMP or other regulated laboratory environments.
• Hands-on experience with HPLC/UPLC and protein analytical techniques is highly preferred.
• Strong documentation and data analysis skills.
• Experience with Microsoft Office; familiarity with SAP, BINOCS, or similar systems is a plus.
• Strong organizational, communication, and time management skills.
• Willingness to work the Wednesday Saturday swing shift schedule.