QC Associate II

Merck & Co.; Fremont (CA); On-site; USD 75,000 - 100,000; Full time

Job summary

Merck & Co. is seeking a QC Analyst to perform routine and non-routine testing of drug substances and finished products in a multi-product facility. You will operate UV-Vis, QPCR, and FTIR instruments, ensuring accurate results and adherence to cGMP standards.

You will maintain inventory, properly dispose of expired reagents, and document all work in compliance with regulatory requirements and site procedures. Strong attention to detail and teamwork are essential.

Qualifications

• 3-5 years of industry experience in QC or analytical testing.
• GMP experience is preferred.
• Bachelor's degree required in biology or life sciences.

Responsibilities

• Execute and coordinate routine and non-routine testing of bulk drug substance, final products, and raw materials.
• Perform UV-Vis, QPCR, FTIR and other compendial analyses following training.
• Maintain inventory of consumables and dispose of expired reagents.
• Document work in compliance with cGMP and cGDP; report deviations.

Skills

Interpersonal communication

Customer focus

Attention to detail

Teamwork

Education

Bachelor's degree in Biology or Life Sciences

Tools

UV-Vis absorbance

QPCR

FTIR

Job description

Duties:

Key Responsibilities

• As part of the QC Phys-Chem Testing team, execute and coordinate routine and non-routine testing of bulk drug substance, final finish products, and raw materials within a multi-product facility.
• Perform laboratory operations independently following appropriate training, including but not limited to: UV-Vis absorbance, QPCR, FTIR and compendial testing.
• Perform essential laboratory support activities such as maintaining inventory of consumables and materials, properly disposing of expired reagents, and identifying and reporting process or equipment anomalies.

Quality, Compliance, and Documentation

• Deliver high-quality analytical results within established timelines, ensuring accuracy "right first time."
• Accurately document all work in compliance with cGMP and cGDP requirements.
• Adhere to all site-specific procedures, regulatory standards, and quality systems.
• Promptly and accurately report deviations, abnormalities, or out-of-specification results.
• Maintain strict adherence to safety standards by recognizing and escalating unsafe conditions or behaviors.

Operational Excellence

• Maintain laboratory workspaces in accordance with established 5S and cleanliness standards.
• Ensure personal training is current and compliant with all regulatory and organizational requirements.

Skills

• 3-5 years of industry experience
• GMP experience is preferred.
• Technical skills preferred: UV-Vis absorbance, QPCR, and FTIR.

The ideal candidate can demonstrate:

• strong interpersonal and communication skills (both written and oral)
• strong customer focus, and an ability to interact with various departments and levels.
• ability to work independently and as part of a team, to meet departmental/facility goals
• able to work across functions to achieve common goals.
• strong attention to detail, and an ability to focus on details of execution.

Education

Bachelors' degree in Biology or Life Sciences required

Schedule Notes

1st Shift: Mon-Fri, 8:00AM-5:00PM

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