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Quality Assurance Specialist - I

El Segundo, CA, United States

Title : Quality Associate Specialist - III

Location : El Segundo, CA 90245 (Need local candidate)

Pay :$57/hr. on W2 Only

***********************************Only local and W2 candidates**********************************

JOB DESCRIPTION:

We are seeking a Senior Specialist of Quality Operations responsible for Product Disposition. This position will participate in Quality activities to ensure compliance with applicable quality objectives and regulatory requirements. This position is located at our El Segundo, CA site and report into the Associate Director of Quality Operations.

NOTE: Position is Day Shift including weekends and requires onsite presence.

Responsibilities

Perform Product Disposition and Lot Closure. Includes commercial and clinical products.

Review batch-related documentation and ensure resolution of issues to release product

Review batch-related shipment documentation to ensure product shipment remained in control

Provide QA oversight and review of deviations tied to lots. Ensure deviations are properly initiated, investigated and resolved in accordance with established disposition timelines.

Provide QA oversight and (limited) approval of CAPAs. Ensures that associated CAPAs are initiated and resolved.

Provide QA oversight and approval of change records. Ensures that change records are initiated and resolved.

Support and participate in investigations, including batch record review.

Ensure process control measures are in place and followed in product manufacturing

Maintain metrics related to product disposition in support of the Management Review

Generate and update procedures, forms and other documents

As assigned, manage and provide QA oversight for other processes, including training, warehouse/inventory, redose, new product introductions, etc.

Generate and report data for management

Maintain production (finite), disposition, and team schedules

Represent Disposition or QA Ops at plant and multi-site scheduling meetings

Provide QA representation on projects and at team meetings

Provide QA representation at multi-site disposition meetings

Support and participate in inspections and audits

Basic Qualifications

Masters Degree and 5+ years of experience in GMP environment OR Bachelors Degree and 7+ years of experience in GMP environment OR High School Degree and 11+ years of experience in GMP environment

Preferred Qualifications

Bachelors degree in the biological sciences or related field and minimum of 7 years progressive experience in a pharmaceutical, biotech, or biologics operation, or equivalent education/work experience.

Working knowledge and ability to apply GMPs in conformance to U.S. and EU standards

Ability to interpret and apply procedural and regulatory guidance in potentially ambiguous situations

Ability to understand risk and provide phase-appropriate appropriate decisions

Ability to effectively negotiate and build collaboration amongst individuals

Good interpersonal skills

Strong written communication skills

Strong analytical skills

Comfortable in a fast-paced small company environment and operate with minimal direction

Ability to adjust workload based upon rapidly changing priorities

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