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Senior QA Specialist

Grimaldi Staffing Services Newark ,CA
  • Expired: May 21, 2020. Applications are no longer accepted.

SUMMARY:

The role is an advanced level position with hands-on QA experience. Working independently and under minimal 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 and systems. In addition to batch record review, this candidate will be responsible for incoming QA, raw material disposition and the reserve sample program. The individual will be interacting with cross-functional groups such as Materials Management, Quality Control, Clinical Packaging & Labeling and Manufacturing.

RESPONSIBILITIES:

  • Perform a wide variety of quality assurance activities to ensure compliance with the company's procedures, applicable US and international regulatory requirements for biologic drug substances and drug products under clinical development
  • Perform incoming quality attribute inspections; review and disposition incoming raw materials (e.g., chemicals, packaging and labeling components, etc.)
  • Perform retain sampling and maintain the reserve sample program
  • Perform line clearance and product inspection
  • Perform product complaints investigations
  • Review documents such as standard operating procedures, master batch records, packaging and labeling records, sampling plans, test methods, specifications, stability protocols and reports, and method validation protocols and reports
  • Review executed production batch records and associated documentation including any deviation and investigation reports related to lot release for biologic drug substance, injectable drug product, clinical trial material, and commercial aseptically manufactured products
  • Act as a compliance resource to provide guidance and assistance towards resolution of moderate deviations, quality investigations, lab investigations, CAPAs and change controls; review and may approve quality system documents related to manufactured products
  • Support continuous improvement of quality operations processes; author new or revise existing department procedures and/or forms
  • Assist in internal compliance audits as needed
  • Provide inspection readiness support and assist during inspections by regulatory authorities
  • May support quality systems as needed (e.g., issue and track closure to change controls, deviations, quality investigations and CAPAs)
  • Provide quality oversight for the labeling, packaging, storage and distribution of clinical trial materials and commercial products.
  • Work with project teams to manage product complaints to resolution or corrective action.
  • Perform CMC section review of regulatory submissions
  • Lead Material Review Boards
  • Develop and report on quality performance metrics
  • Ensure inspection readiness and interface with regulatory agencies as required
  • EXPERIENCE:

  • Minimum of 6 years’ experience in the pharmaceutical or biotechnology industry with at least 4 of those years in QA or closely related fields
  • Good working knowledge of 21 CFR Parts 201, 211, 600, Eudralex Volume 4 and related Annexes, and ICH guidance documents
  • REQUIREMENTS:

  • Good interpersonal and verbal and written communication skills
  • BS or equivalent in biology, chemistry or related science or equivalent experience
  • Experience in aseptic processes is highly desirable and knowledge of biologics is a plus
  • Ability to manage multiple clinical projects
  • Good working knowledge and understanding of US and international (e.g. EU, ICH) cGMP regulations, procedures and guidelines that govern manufacturing, quality control and quality assurance of biologics/drugs produced for clinical trial investigation
  • Attention to detail with an ability to perform critical review of various types of technical documents
  • Proficient with commonly used word processing, database systems and other software
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    Grimaldi Staffing Services

    Address

    Newark, CA
    USA