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Quality Assurance Manager

Aphena Pharma Solutions

Cookeville, TNOnsitePosted 31 days ago
Full TimeMid LevelQuality (QA / QC)CDMO
Original posting ↗

Summary

Develop, implement and manage quality control systems designed to ensure continuous production of advanced composite materials and applications (consistent with established standards, customer specifications and production goals). Supervise a team of quality control inspectors.

Job description

Essential Functions

  • Ensure a high level of customer service. Investigate (and correct) customer issues and complaints relating to quality
  • Supervise workers engaged in Quality inspection and testing activities to ensure high productivity and high technical integrity and provide statistical expertise to teams
  • Develop and analyze statistical data and product specifications to determine standards and to establish quality and reliability expectancy of finished products
  • Formulate, document and maintain quality control standards and on-going quality control objectives
  • Coordinate objectives with production procedures in cooperation with other plant managers to maximize product reliability and minimize costs
  • Create, document and implement inspection criteria and procedures
  • Interpret quality control philosophy to key personnel with company
  • Provide, and oversee, inspection activity for product throughout production cycle
  • Apply total quality management tools and approaches to analytical and reporting processes
  • Interact with vendors to ensure quality of all purchased parts
  • Create and direct environmental test functions and applications
  • Maintain active role on internal Continuous Improvement teams
  • Design, develop and implement quality control training programs
  • Observe and apply organizational policies, laws, rules and regulation
  • Comply with safety regulations and maintain clean and orderly work areas
  • Participate in and complete all company-required training
  • Work on weekends or early mornings, overtime and emergency call out as required
  • Any and all other duties as assigned.

Qualifications

  • B.S. degree in related area desired
  • Prefer minimum of 3 – 5 years of demonstrated experience with this specific job or in a related area
  • Supervisory/Management experience desired
  • Performance Improvement techniques desired
  • Experience with developing / documenting procedure
  • Use of Quality Improvement methods in inspection
  • Computer proficiency
  • Quality orientation and high attention to detail
  • Excellent interpersonal and communication skills
  • Experience working with high performance teams
  • Problem analysis and problem resolution skills

Physical / Mental Demands

  • Normal vision and hearing
  • Frequent standing and walking for long periods
  • Frequent lifting, and moving objects up to 30 lbs consistently with heavier weight
  • Frequent bending, twisting and reaching
  • Occasional pushing and pulling
  • Ability to count and perform mathematical operations
  • Ability to write read and distinguishes numbers and symbols

Requirements

  • B.S. degree in related area desired
  • Prefer minimum of 3 – 5 years of demonstrated experience with this specific job or in a related area
  • Supervisory/Management experience desired
  • Performance Improvement techniques desired
  • Experience with developing / documenting procedure
  • Use of Quality Improvement methods in inspection
  • Computer proficiency
  • Quality orientation and high attention to detail
  • Excellent interpersonal and communication skills
  • Experience working with high performance teams
  • Problem analysis and problem resolution skills

Company overview

Aphena Pharma Solutions is a leading contract pharmaceutical manufacturing and packaging company that provides comprehensive end-to-end solutions for the pharmaceutical, OTC, dietary supplement, animal health, and medical device markets. Founded in 2002 and headquartered in Cookeville, Tennessee, the company operates two FDA- and DEA-registered facilities in the United States with over 762,000 square feet of manufacturing space. With more than 25 years of industry experience, Aphena specializes in contract packaging, repackaging, and manufacturing services, handling solid dose, liquids, gels, creams, ointments, foams, suspensions, and lotion-based products. The company serves as a strategic partner for pharmaceutical companies, offering capabilities in pharmaceutical serialization, track and trace systems, cold chain storage, and supply chain management. Aphena's commitment to quality assurance, regulatory compliance, and customer-centric project management has positioned it as a trusted provider in the contract development and manufacturing organization (CDMO) space, helping clients bring products to market efficiently while maintaining the highest quality standards.

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