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!