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Quality Manager

Company: Simply Biotech
Location: Carrollton
Posted on: June 22, 2022

Job Description:

Quality Manager - Simply Biotech OVERVIEWAre you looking for a new career opportunity with an exciting biotech company?! Then we have got the right team for you! In this role, you are responsible for the duties listed below. Immediate opening for a Quality Manager in Carrollton, TX who possesses:

  • Bachelor's degree required (must have academic/industry Chemistry background)
  • 3+ years of experience as a Quality Manager/Supervisor (team size 5 or more)
  • Quality management experience must be in the Pharmaceutical, Nutraceutical, or Cosmetics industry
  • Must have 21 CFR experience
  • Must have experience with CAPAsFULL DESCRIPTION: To develop, apply and maintain quality standards for sample testing process, documents, methods and procedures that comply with cGMPs, ICH, USP/NF, and FDA regulations and guidelines. The selected candidate will further possess:
    • A minimum of five (5) years in the cosmetic, pharmaceutical, or related field is required.
    • A general working knowledge of GxP, 21 CFR, USP/NF, ICH, cGMP, cGLP and/or ISO standards and guidelines.
    • Ability to access, input, and retrieve information utilizing various software systems.
    • Able to maintain confidentiality and adhere to established laboratory safety practices.
    • Strong communication skills clearly in English, both orally and in writing, with scientific and non-scientific personnel
    • is required.
    • Ability to work efficiently and effectively in a productive manner, as well as ability to shift prioritization of tasks in a
    • fast-paced environment.The selected candidate will be responsible for the following:
      • Manage all activities related to providing required documentation and implementing related documentation systems.
      • Maintain compliance with regulatory requirements, cGMP guidelines, and acceptable scientific practice.
      • Manage and improve tracking and document control systems.
      • Manage research and analysis activities according to applicable government regulations, or other considerations, and approves modification of analyses, tests, and processes.
      • Interpret and implement quality assurance standards in all departments to ensure quality is maintained when handling and testing materials.
      • Review quality assurance standards, study existing policies and procedures, and evaluate effectiveness of quality assurance program.
      • Develop initial and subsequent modifications of quality assurance documentation to delineate areas of responsibility, personnel requirements, and operational procedures within program, according to and consistent with company goals and policies. Write and revise quality assurance policies and procedures.
      • Develop forms and instructions for recording, evaluating, and reporting quality data.
      • Manage review and revision of procedures, specifications, and forms.
      • Review quality assurance standards, study existing policies and procedures, and evaluate effectiveness of quality assurance program.
      • Participate, as member of management team, in formulating and establishing organizational policies and operating procedures for company.
      • Manage activities concerned with development, application, and maintenance of quality standards for internal processes including investigations and CAPAs.
      • Keep abreast of regulatory procedures and changes.
      • Compile all material required for submissions, license renewals, and annual registrations.
      • Develop, implement, and coordinate quality assurance program to prevent or eliminate issues in new methods or existing ones.
      • Suggest and debate alternative methods and procedures in solving problems and testing opportunities.
      • Manage retention of data and preparation of documents for use by self or other company personnel during inquiries and laboratory investigations.
      • Manage training program including materials and training sessions on quality activities.
      • Participate in external, regulatory, and other audits. Coordinate internal audits based on quality assurance criteria.
      • Recommend response to complaints, considering test reports and records, legal standards, and complaint validity.
      • Compile statistical data and narrative reports summarizing quality assurance findings.
      • May operate/maintain equipment, including preventive maintenance of laboratory instruments and safety equipment.
      • Work with all employees at the facility.
      • Work with external departments, such as customer quality assurance and control, customer management, concerning observations and external audits.
      • Attend professional conferences

Keywords: Simply Biotech, Carrollton , Quality Manager, Executive , Carrollton, Texas

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