Quality Control Analyst

Tucker Parker Smith Group (TPS Group); Novato (CA); On-site; USD 65,000 - 95,000; Full time

Job summary

Tucker Parker Smith Group (TPS Group) in Novato, CA, is seeking a QC Analyst to support the In-Process Analytical (QCA-IP) laboratory. You will perform analytical testing on manufacturing intermediates and drug products, ensuring cGMP compliance and accurate documentation.

The ideal candidate has a strong lab foundation, 0–3 years of experience, and familiarity with HPLC/UPLC and protein methods. The role requires swing shift participation and collaboration with QA and manufacturing teams.

Qualifications

• Bachelor's degree in Biology, Chemistry, Biochemistry, Molecular Biology, or related science.
• 0-3 years of lab experience; cGMP/regulatory exposure preferred.
• Hands-on with HPLC/UPLC and protein analyses is highly preferred.
• Strong documentation and data analysis skills.

Responsibilities

• Perform analytical testing on in-process manufacturing samples.
• Execute protein assays including A280, Bradford, UV absorbance, and activity assays.
• Analyze data vs specifications and track trends.
• Document activities per cGMP and GDP requirements.
• Prepare reagents, maintain supplies, and support lab organization.
• Assist with method validation, transfers, and equipment qualification.
• Participate in deviation investigations and process improvement.
• Maintain inspection readiness and assist with housekeeping.
• Train junior analysts on qualified methods.
• Collaborate with Manufacturing and QA to ensure timely testing.

Skills

Analytical testing

Documentation

HPLC/UPLC

Protein assays

Data analysis

SAP/BINOCS familiarity

Education

Bachelor's degree in Biology/ Chemistry/ Biochemistry/ Molecular Biology

Tools

HPLC

UPLC

A280

Bradford assay

Job description

Duration: 1-year contract with potential to extend or convert

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 Responsibilit

• iesPerform analytical testing on in-process manufacturing samples using established metho
• ds.Execute protein assays including A280, Bradford, UV Absorbance, enzyme activity assays, and HPLC/UP
• LC.Analyze and interpret data against specifications and trending requiremen
• ts.Document laboratory activities in accordance with cGMP and GDP requiremen
• ts.Prepare reagents, maintain laboratory supplies, and support laboratory organizati
• on.Assist with method validation, method transfers, equipment qualification, and technical investigatio
• ns.Participate in deviation investigations and support continuous process improvemen
• ts.Maintain laboratory inspection readiness and assist with housekeeping activiti
• es.Train junior analysts on qualified laboratory methods as appropria
• te.Collaborate closely with Manufacturing, Quality Assurance, and other cross-functional teams to ensure timely sample testi

ng.

Qualificat

• ionsBachelor's degree in Biology, Chemistry, Biochemistry, Molecular Biology, or a related scientific discipl
• ine.0-3 years of laboratory experience (QC experience preferr
• ed).Experience working under cGMP or other regulated laboratory environme
• nts.Hands-on experience with HPLC/UPLC and protein analytical techniques is highly prefer
• red.Strong documentation and data analysis ski
• lls.Experience with Microsoft Office; familiarity with SAP, BINOCS, or similar systems is a p
• lus.Strong organizational, communication, and time management ski
• lls.Willingness to work the Wednesday-Saturday swing shift sched