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Quality Assurance Specialist

Company: Spectrum Chemical Mfg. Corp.
Location: Gardena
Posted on: March 16, 2020

Job Description:

SummaryAssist customers with various quality documentation requests regarding Spectrum's Quality Management System.
Assist Spectrum Sales team by providing quality-related documentation as requested.Assist in assuring that Spectrum operates in accordance to current Good Manufacturing Practices & regulations and in compliance to ISO 9001:2015 Quality standards.
Essential Duties And Responsibilities Include The Following As Assigned

  • Complete Customer Quality Surveys & Questionnaires
  • Coordinate Quality / Technical data requests: such as Customer Spec Sheets, or Certificates of Origin, Stability Data, GMP Certifications, etc.
  • Perform Internal Quality Audits
  • Assist in hosting Customer Quality System Audits and or Regulatory Inspections
  • Maintain and continual development of Scientific Documentation/Quality Response Package Maintain Supplier Qualification Program o Evaluating supplier self-audit questionnaire o Performing site quality system audits o Tracking supplier performance o Responsible for Supplier Corrective Action Request (SCAR) o Establishment of Quality Agreements/Clauses o Supply chain resolution o Maintain and monitor CofA challenge
    • Maintain Customer Change Control Program and Notification Support to affected parties
    • Assist with quality investigations
      Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
      Education and/or Experience
      • Knowledge of Quality System requirements of ISO 9001:2015, current Good Manufacturing Practices 21 CFR 210& 211, IPEC PQG, and ICH Q7/A.
      • Must have basic computer literacy including familiarity of programs such as Word, Excel and Pagemaker, Filemaker.
      • Bachelor's degree (BA/BS) from four-year college or university. Training in Quality System Auditing highly desired.-- Lean process improvement and Six Sigma, 5 S experience and background preferred
        Language Skills Must have strong oral and written communication skills and be able to manage multiple tasks. Ability to read, analyze and interpret common scientific and technical journals, financial reports and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to effectively present information to top management, public groups, and/or members of senior management. Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
        Mathematical Skills Ability to calculate proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.
        Reasoning Ability Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
        Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Keywords: Spectrum Chemical Mfg. Corp., Gardena , Quality Assurance Specialist, Other , Gardena, California

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