Position Title: QC Associate II
Work Location: Fremont, CA 94555
Assignment Duration: 6 Months
Work Schedule: 2nd Shift: Wed-12 Noon- 9 PM, Thurs-Sun, 12 Noon-11 PM. (For the first 3 months (approximately), schedule will be 1st Shift: Mon-Fri, 8 AM - 5 PM for training.)
Work Arrangement: Onsite
 
Position Summary: 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.
 
Key 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.

 
Qualification & Experience:

• 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.

• Bachelors' degree in Biology or Life Sciences required

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 31.00/hr.