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Sr. Quality Assurance Specialist (Oversight to Manufacturing)

Company: Med-pharmex Inc.
Location: Pomona
Posted on: January 13, 2022

Job Description:

Sr. Quality Assurance Specialist (Manufacturing)
The Quality Assurance Specialist is responsible for a variety of Quality activities on the shop floor to ensure compliance with applicable quality objectives and regulatory requirements in the cGMP Quality organization.
Duties and Responsibilities:

  • Work with Manufacturing Department as a production area Quality Assurance (QA) representative.
  • Provide on-the-floor QA oversight and support to ensure compliance to GMP throughout the area.
  • Review batch-related documentation and ensure resolution of issues to ensure timely disposition of product.
  • Communicate lot disposition pending issues to Management.
  • Identify compliance risks and escalate the issues to appropriate levels of management for resolution.
  • Generate and update standard operating procedures and forms as needed.
  • Review and approve manufacturing procedures.
  • Gather quality metric information for use in continuous improvement of areas of responsibility.
  • Review and approve proposed changes to systems, procedures, and methods.
  • Perform risk assessment.
  • Provide QA oversight of Facilities and warehouse.
  • Perform quality review and/or investigations of manufacturing deviations, GMP and Quality System issues, non-conforming materials, and CAPA, as needed.
  • Review and approve validation-related documents, as needed.
  • Perform other duties as required to fulfill department and business needs.
    • A minimum Bachelors degree in a scientific discipline is preferred with 5 years of experience in a pharmaceutical industry.
      • Familiarity with Good Manufacturing Practices (cGMP's) and Good Laboratory Practices (GLP).
      • Experience with manufacturing investigations, deviations, and CAPA.
      • Experience with change control practices and strategies.
      • Experience with internal and external audits.
      • Knowledge of equipment, facility, and utility IQ/OQ/PQ.
      • Knowledge of relevant ICH and FDA guidance documents.
        Position Type/Expected Hours of Work
        This is a full-time on-site position, and hours of business operations are Monday through Friday, 8:30 a.m. to 5 p.m. Must be available to work extended hours (first shift is 6 a.m. to 2:30 p.m.) as needed to meet deadlines, including weekends from time to time.
        Med-Pharmex, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Keywords: Med-pharmex Inc., Pomona , Sr. Quality Assurance Specialist (Oversight to Manufacturing), Other , Pomona, California

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