QC Associate

37281109 QC Associate Fremont, CA 6 Months

Sigma Inc is currently looking for a QC Associate to work in with our client in Fremont, CA

2nd Shift: Wed-12Noon-9PM, Thurs-Sun, 12Noon-11PM. Mon-Fri, 1st shift for the first 3 months (approximately) for training. Wed-Sat, 2nd Shift after the training period.

Responsibilities:

• As part of the QC In-Process Testing (IPC) team, execute and coordinate routine and non-routine testing of bulk drug substance and intermediates within a multi-product facility.
• Perform laboratory operations independently following appropriate training, including but not limited to: HPLC titer, UV-Vis absorbance, endotoxin testing, pH, osmolality, total organic carbon (TOC), conductivity, and sample aliquotation.
• 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.

Requirements:

• Bachelor's degree in biology or Life Sciences required
• 3-5 years of industry experience GMP experience is preferred.
• Technical skills preferred: HPLC (titer), aseptic technique, osmolality, total organic carbon (TOC), conductivity

The ideal candidate can demonstrate:

• Strong interpersonal and communication skills (both written and oral), a 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; is also able to work across functions to achieve common goals
• Strong attention to detail, and an ability to focus on details of execution.