• Sr. Quality Specialist, Manufacturing Quality

    Job ID 2019-1550
    Job Locations
    US-CA-Seal Beach
    Category
    Quality Assurance
  • Overview

    The Sr. Quality Specialist, Maufacturing Quality is responsible for  performing a wide variety of QA activities to ensure compliance with applicable regulatory requirements. 

    Responsibilities

    Responsibilities:

    • Performs batch record preparation, issuance, batch record review and disposition.
    • Issuance of controlled labels and forms.
    • Ensures full GMP compliance for the disposition of raw materials and components.
    • Tracks and trends deviations, non-conformances, corrective actions, OOS, change controls, investigations and other metrics in support of management review.
    • Review and approve qualification and validation protocols and reports.
    • Provide oversight of the change control technical assessment/evaluation process and manage escalation of changes beyond site.
    • Conduct product complaint investigations
    • Provides support in one or more of the following:
      • Review and approval of change controls.
      • Investigation and recall of non-conforming materials.
      • Investigations associated with product failures, product complaints and BPDRs.
      • Review and approve GMP facility work orders and validation activities
      • Support FDA/Regulatory Agency inspections
    • Represents department in cross-functional teams, projects and GXP-related problem resolution.

    Scope:

     

    • Uses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways.
    • Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
    • May determine methods and procedures on new assignments and may provide guidance to other lower-level personnel.
    • Some travel may be required.

    Qualifications

    • Bachelor’s degree in a scientific discipline or equivalent.
    • Proficient in MS Office applications.
    • 10 years related experience in cGMP/FDA regulated industry.
    • Knowledge of cGMP/QSR and FDA device/drug/biologics regulations.

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