R&D Partners is seeking to hire a Quality Assurance Specialist II in Newark, CA.
A commercial stage biotechnology company focused on innovative aesthetic, therapeutic and financial technology offerings, setting a new standard in healthcare, is seeking a Quality Assurance Specialist II. This is an intermediate level position with hands-on QA experience. Under moderate supervision, the individual will be working primarily on quality systems, the reserve sample program and incoming attribute inspections. The individual will also assist in quality operations area, such as batch record and quality control data review, line clearances, AQL inspection, and will be interacting with cross-functional groups such as Quality Control, Manufacturing and Regulatory Affairs.
Your main responsibilities as a Quality Assurance Specialist II (Reviewer):
- 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 are looking for in a Quality Specialist II:
- Minimum 4 year's 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.
Why Choose R&D Partners?
As an employee, you have access to a comprehensive benefits package including:
- Medical insurance – PPO, HMO & HSA
- Dental & Vision insurance
- 401k plan
- Employee Assistance Program
- Long-term disability
- Weekly payroll
- Expense reimbursement
- Online timecard approval
Pay Scale:
- $85,000 – $91,700 (Dependent on Experience)
R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
R&D Partners is an equal-opportunity employer.
