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Senior Specialist of Quality Operations

El Segundo, CA 90245

Posted: 06/28/2024 Employment Type: Contract Job Category: Quality and Compliance Job Number: 608626 Is job remote?: No Country: United States

Job Description


Target PR Range: 44-54/hr
*Depending on experience

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.

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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About El Segundo, CA

Ready to kickstart your career in El Segundo, California? This vibrant coastal city, nestled in Los Angeles County, offers a unique blend of beachfront charm and bustling business opportunities. Known for being home to numerous aerospace and tech companies, El Segundo provides a fertile ground for career growth and innovation. With its proximity to iconic landmarks like the Manhattan Beach Pier and the El Segundo Museum of Art, as well as a diverse culinary scene ranging from tasty food trucks to upscale dining experiences, this area has something for everyone. Explore job opportunities in El Segundo today and discover a career path that combines professional success with a relaxed and inspiring coastal lifestyle.

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