Senior Quality Control Analyst

United Pharma; California (MO); On-site; USD 85,000 - 135,000; Full time

Job summary

United Pharma is seeking an experienced Senior QC Analyst to join the Quality Control team in a GMP-regulated environment. The role focuses on hands-on HPLC analysis and compendial testing to support raw materials, in-process samples, drug substance, and finished products.

Experience with biologic or molecular assays is advantageous but not mandatory. You will collaborate with QC, QA and manufacturing to meet release timelines while ensuring GDP-compliant documentation.

Qualifications

• Hands-on experience with HPLC testing in GMP-regulated QC labs.
• Experience performing USP/NF and other compendial testing.
• Ability to independently execute analytical methods and troubleshoot.
• Understanding of GMP, data integrity, and controlled documentation.
• Experience supporting OOS/OOT investigations and deviations.
• Experience with method transfer, verification, or validation preferred.
• Experience with ELISA, RiboGreen or molecular assays a plus.

Responsibilities

• Perform routine HPLC analysis and analytical testing in a GMP QC lab.
• Execute USP/NF and compendial methods per procedures.
• Test raw materials, in-process materials, drug substance, and finished products.
• Prepare samples, standards, mobile phases, reagents, buffers, and controls.
• Operate, maintain, troubleshoot HPLC systems and lab equipment.
• Review and document analytical results per GMP/GDP.
• Participate in OOS, OOT, deviations and investigations.
• Support method transfers, verification, and validation activities.
• Ensure equipment and records are inspection-ready.
• Collaborate with QC, QA, Manufacturing and Analytical Development.
• Conduct auxiliary testing such as ELISA, RiboGreen, or molecular assays as needed.

Skills

HPLC testing

GMP QC laboratory

Data integrity

Method troubleshooting

Analytical method transfer

Documentation (GDP)

OOS/OOT investigations

Team collaboration

Tools

HPLC systems

Job description

Our pharmaceutical client is seeking an experienced Senior QC Analyst to join their Quality Control team within a GMP-regulated manufacturing environment. The role will primarily focus on hands‑on HPLC analysis and compendial testing to support raw materials, in‑process samples, drug substance, and finished products. Experience with biologic or molecular assays is advantageous but not mandatory.

Key Responsibilities

• Perform routine HPLC analysis and other analytical chemistry testing in a GMP‑compliant QC laboratory.
• Execute USP/NF and other compendial methods in accordance with approved procedures, methods, and specifications.
• Conduct analytical testing for raw materials, in‑process materials, drug substance, and finished products.
• Prepare samples, standards, mobile phases, reagents, buffers, and controls following approved procedures.
• Independently operate, maintain, troubleshoot, and perform basic problem‑solving on HPLC systems and laboratory equipment.
• Accurately review, record, and document analytical results in compliance with GMP and Good Documentation Practices (GDP).
• Participate in OOS, OOT, deviation, and other laboratory investigations associated with analytical testing.
• Support analytical method troubleshooting, method transfers, method verification, and validation activities.
• Ensure laboratory equipment, instruments, records, and documentation remain compliant and inspection‑ready.
• Collaborate with QC, QA, Manufacturing, and Analytical Development teams to meet testing and product‑release timelines.
• Perform additional analytical testing, such as ELISA, RiboGreen, molecular assays, or other biologic‑related testing, based on laboratory requirements.

Required Qualifications

• Strong hands‑on experience with HPLC testing in a pharmaceutical, biotechnology, or GMP‑regulated QC laboratory.
• Demonstrated experience performing USP/NF and other compendial analytical testing.
• Proven ability to independently execute analytical methods and troubleshoot HPLC and laboratory testing issues.
• Solid understanding of GMP requirements, laboratory practices, data integrity, and controlled documentation.
• Experience supporting OOS/OOT investigations, deviations, and laboratory investigations.
• Experience with analytical method transfer, verification, or validation is preferred.
• Experience with ELISA, RiboGreen, molecular assays, or biologic products is a plus, but not required.