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.
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
Applicant Notices & Disclaimers
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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.
