QC Associate II

Quality Control In-Process Testing (Ipc) Technician

Pay rate: $30.00 - $35.00/hr Hours: 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. Location: Fremont, CA Duration: 6 months

Summary of 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.

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 experience GMP experience is preferred.

Technical skills preferred: HPLC (titer), aseptic technique, osmolality, total organic carbon (TOC), conductivity 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

Benefits (employee contribution):

• Health insurance
• Health savings account
• Dental insurance
• Vision insurance
• Flexible spending accounts
• Life insurance
• Retirement plan

All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Rate of pay within the stated range will depend on the qualification of the applicant.

We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records. For Los Angeles, CA applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.