QA Specialist II

Contract: El Segundo, California, US

Salary: $50.00 Per Hour

Job Code: 350996

End Date: 2024-11-01

Days Left: 26 days, 15 hours left

To discuss more about this job opportunity, please reach out to Chitrank Rastogi (LinkedIn URL - https://www.linkedin.com/in/chitrank-rastogi-55119a102/), email your updated resume at Email - chitrank.rastogi@collabera.com or give me a call at (425) 523-1648. Thank you!


Pay Range - $45 to $50/hr. (negotiable)


Job Description:
Job Roles & Responsibilities:

  • 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.

 

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:

  • Master’s Degree and 5+ years of experience in GMP environment OR
  • Bachelor’s Degree and 7+ years of experience in GMP environment OR
  • High School Degree and 11+ years of experience in GMP environment

 

Preferred Qualifications:

  • Bachelor’s 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

 

Job Requirement
  • QA Specialist
  • Quality Assurance
  • Quality Operations
  • CAPA
  • Documents
  • biological sciences
  • GMP
  • cGMP
  • GDP
  • Biotechnology
  • Pharma
  • Pharmaceuticals
Reach Out to a Recruiter
  • Recruiter
  • Email
  • Phone
  • Chitrank Rastogi
  • chitrank.rastogi@collabera.com
  • 4255231648
Apply Now
Apply Now
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