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Director of Quality

Company: Central Missouri Community Action
Location: Idaho Falls
Posted on: May 13, 2022

Job Description:

Participates, as member of management team, in evolution and sustainment the Quality System consisting of product quality assurance and quality control programs, standard operating procedures (SOP's), organizational policies, and compliance activities for the company. Essential Duties and Responsibilities

  • Acts as the Management Representative for the Quality Unit for the site.
  • Develops, implements, and coordinates, through support staff, a product quality program to prevent or eliminate defects in new or existing products including but not limited to incoming raw materials, packaging components, process water, bulk product batches and finished goods.
  • Communicates customer product specifications and requirements and suggests and debates alternative methods and procedures in solving problems and meeting changes with these specifications.
  • Development, revision, implementation and auditing of Standard Operating Procedures for the site in accordance to customer compliance requirements and regulations.
  • Reviews quality assurance standards, studies existing policies and procedures, and interviews company personnel and customers to evaluate effectiveness of the quality assurance program.
  • Conducts management and training meetings with any/all applicable company personnel to establish, delineate, and review standard operating procedures, organizational policies, and coordinate cross-departmental functions.
  • Lead Quality Assurance and Quality Control staff.
  • Cooperates with other top management personnel in formulating and establishing company policies, Standard Operating Procedures, and KPIs.
  • Develops, implements, revises and audits Standard Operating Procedures for the Company in accordance to governing regulations including FDA, ATF, OSHA, and ISO.
  • Reviews technical problems and SOP's of the Company and recommends solutions to problems or changes in procedure(s).
  • Submits the required regulatory documents and reports for the Company in accordance to governing regulatory agencies including FDA, ATF, OSHA, ISO, and other state and local agencies.
  • Oversees compliance with other standards and certifications (Organic, RSPO, GFCO, etc).
  • Reviews, audits and/or approves all Master Formulas and Bill Of Materials for their accuracy.
  • Oversees the performance and interpretation of plant hygiene studies conducted on a quarterly basis.
  • Oversees the performance and corrective actions of the Internal Audit program on a quarterly basis.
  • Maintains complaint, change control and CAPA programs and leads investigation and effectiveness activities.
  • Evaluates contents of reports from the Quality Control department and other Company managers.
  • Must be able to perform the essential job functions with or without reasonable accommodation without posing a direct threat to the individual or others.
    Additional
    • Confers with top management personnel regarding financial decisions and fiscal budgets for Quality Assurance Department and Company.
    • Handles all regulatory agency and customer-based compliance inspections and manufacturing facility audits.
    • Confers with representatives of raw material and package component vendors to obtain information related to supply quality and vendor quality standards.
    • Reviews technical publications, articles, and abstracts to stay abreast of technical developments in the drug, medical device, cosmetic and personal care product industries.
    • Performs other duties as assigned or needed. Elevation Labs provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, Elevation Labs complies with applicable state and local laws governing nondiscrimination in employment at every location in which the Company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. The essential duties listed are representative of the major duties required of this job; ability to perform the essential functions with or without reasonable accommodation is required. Elevation Labs may make reasonable accommodation to the known physical or mental limitation of otherwise-qualified individuals with disabilities unless the accommodation would impose an undue hardship on the operation of our business.
      This job description is not designed or intended to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required for this job. Specific duties and responsibilities may vary based upon departmental needs. Incumbent may be asked to perform other duties as assigned. Qualifications
      • College degree (A.S. or B.S.) in a related field and 5 years of quality management experience in a related industry.
      • Experience and knowledge in Cosmetic, Personal Care, OTC drug, and Medical Device regulations with FDA, Health Canada and other Foreign Markets.
      • Knowledge of ISO standards, specifically ISO 22716 and ISO 13485.
      • Flexibility and ability to handle multiple tasks in a short amount of time.
      • Knowledge of personal computers and Microsoft Office applications.
      • Ability to perform basic mathematical calculations (addition, subtraction, multiplication, division, percentages, etc.).
      • Performs work using good organizational and time management skills.
      • Performs work with a high degree of accuracy and attention to detail.
      • Communicates by written and/or verbal means the nature of out-of-specification test results.
      • Works with minimum supervision.
      • Perform essential duties and responsibilities efficiently, accurately and safely. Additional
        • Ability to climb stairs.
        • Ability to lift up to 40 pounds on an occasional basis. Machines Operated Laboratory equipment including, but not limited to:
          • pH,meter,
          • Viscometer
          • Refractometer
          • FTIR
          • Copy machine
          • Personal computer
            Physical/Mental Demands:
            • Regularly required to sit, stand, walk, stoop, kneel, bend
            • Regularly use hands to keyboard or type, handle materials, or manipulate tools
            • Regularly reach with hands and arms
              • Requires composure and ability to prioritize and handle many urgent tasks and requests simultaneously with a high level of competence and accuracy
              • Maintain confidentiality
              • Willing to travel, if needed (minimal)Sufficient clarity of speech and hearing abilities required by this classification includes those which permit the employee to discern verbal instructions and communicate effectively in person and by telephone The physical demands identified above are representative of those that will be required to successfully perform the essential functions of this job.

Keywords: Central Missouri Community Action, Idaho Falls , Director of Quality, Executive , Idaho Falls, Idaho

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