QC Associate II

Job Title: QC Associate II
Location: Fremont, CA
Duration: 6 months

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

Job Description:
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.
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 expereince 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.
Education: Bachelors' degree in Biology or Life Sciences required