Quality Assurance Specialist II, Tap Growth ai, CA, US

🌟 We're Hiring: Quality Assurance Specialist II! 🌟

We are seeking to hire a Quality Assurance Specialist II in Newark, CA.

📍 Location: Newark, United States

⏰ Work Mode: Work From Office

💼 Role: Quality Assurance Specialist II

Pay Scale: $85, 000 – $91, 700 (Dependent on Experience)

What You'll Do

∙Perform a wide variety of quality assurance activities to ensure compliance with

procedures, applicable US and international regulatory requirements for biologic drug

substances and drug products under clinical development.

∙Assist in the management of the reserve sample program.

∙Perform incoming quality attribute inspections.

∙Review, approve, and track closure of the change controls, deviations, quality

investigations and CAPAs.

∙Prepare quality system metrics.

∙Review and disposition of incoming raw materials.

∙May support quality operations, as needed (e.g., review executed records such as batch

records/ quality control data or equipment qualifications; perform line clearance and

product inspection; review other records under supervision such as change control

requests, deviations, lab investigations, environmental monitoring excursions, proposed

CAPAs).

∙Support continuous improvement of quality systems. Author new, revise existing

department procedures and/or forms.

What We're Looking For

∙ Minimum 4 years' experience performing quality functions in pharmaceutical and/or

biotech related fields.

∙Some working knowledge of quality systems cGMP standards applicable to clinical

biologics DS and DP.

∙Works under moderate supervision.

∙Ability to independently analyze and reconcile simple issues.

∙Ability to organize and manage multiple tasks in a fast-paced environment, with minimal

instruction on routine work and moderate instructions on new assignments.

Ready to ensure excellence? 🚀 Apply now and let's build quality together!