Quality Assurance Specialist in Newark, CA

This is a fully onsite role.

Position to provide support for fosun DP planning that was endorsed by finance and ecomm. 

Notes:

• Bachelors degree required
• 3-4 years of experience minimum
• QA and QC experience ideal
• Prefers more QC experience than QA but both are nice to have
• Experience with investigations, deviations, capas, change controls
• Good Communication skills
• Good Organizational skills
• Electronic system experience nice to have
• Top 3 skills - QA/QC experience, approver/writinng deviations/capas, collaboration and communication skills
• Prefer local candidates
• Main system is Veeva for change controls/deviations
• Team size - 8 people in PQA group, group collaborates closely

Job summary:

• The Quality Assurance Specialist II 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.

Essential duties:

• Perform a wide variety of quality assurance activities to ensure compliance with Client 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.
• Assist in internal compliance audits as needed.
• Provide inspection readiness support and assist during inspections by regulatory authorities or other third parties.
• Other duties as assigned.

Experience:

• 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.
• Good verbal and written communication and interpersonal skills.

Preferred additional skills (i.e., computer):

• Proficient with commonly used word processing, database systems and other software.

Education:         

• BS or equivalent in biology, chemistry or related science or equivalent experience.

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