Quality Assurance Manager

| Greater Denver Area
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POSITION SUMMARY

The Quality Assurance Director oversees the day to day quality-operations. This role ensures that Quality systems are monitored and followed.  The Quality Assurance Director is responsible for all matters related to quality under the FDA’s GMP guidelines. These responsibilities include supervising quality personnel, procuring, producing and maintaining all quality documents, qualifying manufacturers, producing and implementing SOPs, producing CAPAs, creating batch records and checking Certificates of Analysis.

CORE JOB DUTIES & RESPONSIBILITIES

  1. Expert knowledge of the 4 corner stones of a quality system (roles and responsibilities, training, quality event management, supply chain management).
  2. Responsible for Company compliance with FDA’s GMP guidelines.
  3. Manages all quality documents.
  4. Conducts daily GMP audits and follow up.
  5. Responsible for the system and the accuracy of all required GMP documents.
  6. Leads the investigation and resolution of low-medium quality incidents, product holds, customer & consumer complaints.
  7. Oversees all Certificates of Analysis and creates Specification Sheets.
  8. Sets and maintains CSI Quality Assurance guidelines regarding quarantine, damaged goods, re-work, ingredient testing frequency, and other product quality issues.
  9. Oversees handling damaged goods, returns and expired inventory; ensures the use of appropriate paperwork including RMAs, certificates of destruction, etc.
  10. Acts as a liaison with new product development to establish new item numbers and qualify new ingredients and manufacturers.
  11. Manages the tracking and disposition of expiring inventory.
  12. Acts as the Sanitation Supervisor per SOPs, overseeing sanitation site wide.
  13. Responsible for initial and ongoing team quality training.
  14. Creates, implements and maintains all quality-related SOPs.
  15. Responsible for item number system maintenance and new item number creation.
  16. Uses appropriate system to transfer, destroy, and report damaged inventory; works cooperatively and collaboratively with the Warehouse, Imports & Inventory, Accounting, and Customer Service.
  17. Performs other duties as assigned.

ADDITIONAL DUTIES AS REQUIRED

  • Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

JOB QUALIFICATIONS

  • Bachelor’s Degree in related field required
  • 5+ years of Quality Management experience
  • Full understanding and experience in GMP's, Product Safety & Security.
  • Have a working knowledge of SPC (Statistical Process Control) applications and implementation
  • Pays impeccable attention to all details
  • Shows excellent critical thinking skills
  • Displays excellent retention skills
  • Demonstrates mastery of basic math and algebra with some knowledge of chemistry or chemical nomenclature
  • Ability to accomplish goals and complete projects successfully and on schedule
  • Establishes and maintains honest, effective relationships with employees, customers, and vendors
  • Adapts to change and shifts gears comfortably
  • Demonstrates excellent phone and email etiquette
  • Works independently, works well under pressure and meets deadlines
  • Utilizes relevant experience and resources to be productive and efficient in planning and executing work
  • Prioritizes tasks and time efficiently
  • Seeks input and advice from colleagues in order to receive more successful results pertaining to reports and projects. Focuses on the achievement of goals that produce results

 

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