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QA Operations Specialist II - $8,000* Sign On

United States - California - El SegundoQualityRegular

Job Description

We are seeking a highly motivated individual to join us as a Specialist II, QA Operations at the commercial manufacturing site in El Segundo. 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 Sr. QA Manager, Quality Operations.

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

Responsibilities

  • Review batch-related documentation and ensure resolution of issues to release product.
  • Perform comprehensive quality review of batches for disposition.
  • Ensure process control measures are in place and followed in product manufacturing
  • Ensure all product-related Deviations are initiated, investigated and resolved.
  • Ensure that associated CAPAs are initiated and resolved, as needed.
  • 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.
  • Maintain production (finite), disposition, and team schedules
  • Represent Disposition or QA Ops at plant and multi-site scheduling meetings
  • Provide QA representation at multi-site disposition meetings
  • Provide QA representation on projects and at team meetings
  • Maintain metrics related to product disposition in support of the Management Review and for continuous improvement
  • Support and participate in inspections and audits

Basic Qualifications:

  • Master’s Degree and 2+ years’ experience in a pharmaceutical, biotech, or biologics operation OR
  • Bachelor’s Degree and 4+ years’ experience in a pharmaceutical, biotech, or biologics operation OR
  • AA Degree and 5+ years’ experience in a pharmaceutical, biotech, or biologics operation OR
  • High School Degree and 6+ years’ experience in a pharmaceutical, biotech, or biologics operation

Preferred Qualifications:

  • 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
  • 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

Does this sound like you? If so, apply today!

* This Position qualifies for a $8,000 Sign-on Bonus, $4,000 payable within 30 days of start date and $4,000 payable following 6 months of continuous employment. Payments are subject to a 1-year repayment agreement from date of payment issue. Applies to external hires only.