QC Associate II

.Position Title: QC Associate II
Work Location: Fremont, CA 94555
Assignment Duration: 6 Months
Work Schedule: 1st Shift: Mon-Fri, 8:00AM-5:00PM

Position Summary: 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.

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

Qualification & Experience:

• 3-5 years of industry experience
• GMP experience is preferred.
• Technical skills preferred: UV-Vis absorbance, QPCR, and FTIR.
• 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.
• Bachelors' degree in Biology or Life Sciences required