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QA Specialist III - Clinical Biologics

Company: Grimaldi Staffing Services
Location: Newark
Posted on: February 24, 2021

Job Description:

General Description

The Quality Assurance Specialist III is an advanced level position with hands-on QA experience. Working independently and under minimum supervision, the individual will be working primarily in quality operations providing quality assurance support to CMC teams and to in-house DS and DP production, testing and systems. The individual will be interacting with cross-functional groups such as Materials Management, Validation, Quality Control, and Manufacturing departments.

Responsibilities

  • 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 and commercial manufacturing
  • Perform incoming quality attribute inspections; review and disposition of incoming raw materials (e.g. chemicals, packaging and labeling materials, components etc.)
  • Review documents such as standard operating procedures, master batch records, packaging and labeling records, sampling plans, test methods, qualification protocols, and reports
  • Review executed production batch records and associated documentation including any deviation and investigation reports related to lot release
  • Perform retain sampling and support the reserve sample program
  • Perform area approval, line clearance and product inspection
  • Perform product complaints investigations
  • Actively update department databases to ensure up-to-date reporting of metrics
  • Support continuous improvement of quality operations and department databases; author new, revise existing and may review department procedures and/or forms
  • Support quality systems, as needed (e.g., issue and track closure to change controls, deviations, quality investigations, CAPAs)
  • Assist with inspection preparation and inspection strategy room for regulatory agency inspection or third party audits
  • Act as a compliance resource to provide guidance and assistance towards resolution of simple to moderate deviations, quality investigations, lab investigations, CAPAs and change control; review and may approve quality system documents related to manufactured products
  • Assist in data verification of DS and DP sections of regulatory submissions as needed
  • Assist in the internal compliance audits as needed
    EDUCATION

    Minimum Required:
    • BS or equivalent in biology, chemistry or related science

      Qualifications

      Minimum Required:
      • Minimum 4-6 years experience in the pharmaceutical or biotechnology industry with at least 4 years working in direct manufacturing or performing quality functions; experience in aseptic manufacturing processes is highly desirable
      • Ability to work with all levels cross-functionally
      • Good working knowledge and understanding of 21 CFR Parts 210, 211, 600, Eudralex Volume 4 and related Annexes, and ICH guidance documents
        Preferred:
        • 6 years of experience in the pharmaceutical or biotechnology industry with at least 4 years working quality operations involving aseptic fill, finish, and packaging operations

          Knowledge, Skills And Abilities
          • Excellent interpersonal and verbal and written communication skills
          • Good working knowledge of quality systems cGMP standards applicable to clinical biologics DS and DP
          • Works independently with minimum supervision to accomplish goals
          • Relies on extensive experience and judgment to resolve simple to moderately complex issues
          • Ability to organize and manage multiple tasks in a fast-paced environment, with no instruction on routine work and general instructions on new assignments
          • Prior experience with regulatory inspections is desired
            Please Note: You will be required to successfully complete a Security Risk Assessment (SRA) via the CDC

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Keywords: Grimaldi Staffing Services, Newark , QA Specialist III - Clinical Biologics, Healthcare , Newark, California

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