Quality Assurance Specialist

3 weeks ago

Newark, United States Integrated Resources, Inc ( IRI ) Full time

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 *** procedures, applicable US and international regulatory requirements for biologic drug substances and drug products under clinical development.

• Manage the reserve sample program.

• Perform incoming quality attribute inspections.

• Coordinate 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.

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