Quality Assurance Manager



GENERAL PURPOSE: Develop and implement a quality system to ensure consistency of product to the customer through facilitation, development and training of management and key personnel. Ensure compliance with all company policies and procedures. 


  • Facilitates development, implementation and compliance of Quality System.
  • Maintains an internal audit system
  • Acts as gatekeeper of document control system.
  • Facilitates customer audits.
  • Manages calibration system.
  • Provides development and training of management in quality system and quality improvement tools.
  • Completes GMP training and tracks competency.
  • Provides technical assistance to production department.
  • Actively participates as a member of corporate quality team.
  • Plans and completes supplier, subcontractor and internal quality audits.
  • Locates, evaluates, purchases and implements technology to promote quality objectives.
  • Evaluates procedures for compliance to quality objectives.
  • Facilitates and participates in quality meetings; both internal and external (i.e., customer walkabouts, ALC, etc.).
  • Coordinates and directs customer incident reviews; manages the CAPA system.
  • Provides supervision to others through motivation, direction, review or feedback of assigned tasks related to quality systems and tools
  • Performs other job duties as assigned.
  • Coordinates testing and measurement program.
  • Determines inspection and release criteria
  • Completes specification review and interpretation to shop floor.
  • Develops and deploys adequate internal specifications to meet or exceed customer requirements.
  • Executes facility improvement initiatives as determined from performance data.
  • Provides daily quality feedback to the site and regional leadership.
  • Actively aligns facility quality systems with corporate systems.
  • Implements and executes facility and corporate policies as required.
  • Tracks, analyzes, and leads initiatives for all internal quality and customer complaint issues.
  • Formulates and maintains quality control objectives and coordinates objectives with production.
  • Works closely with production managers to maximize product quality and reliability and to minimize cost.
  • Plans, promotes and organizes training activities related to product quality and reliability.


  • Must have Bachelor's Degree from an accredited four-year college or university and three to five years of quality control or other related experience or equivalent combination of education and experience.
  • Pharmaceutical experience preferred.
  • ISO experience preferred.
  • Must have the ability to effectively present information in one on one and small group situations to customers, clients and other employees of the organization.
  • Must have the ability to respond to common inquiries or complaints from customers, regulatory agencies or members of the business community.
  • Must have strong communication skills.
  • Effective interpersonal communication skills.
  • Must have the ability to write routine reports and business correspondences.
  • Must have the ability to read, analyze and interpret common scientific and technical journals, financial reports and legal documents.
  • Must have the ability to effectively present information to top management.
  • Must be a strong software user, including competency in Microsoft Access, Excel spreadsheets, and Power Point.
  • Must have advanced mathematical ability.
  • Must have the ability to establish, maintain and retrieve permanent files.
  • Must be capable of maintaining good attendance.
  • Must pass color vision and color hue vision tests.
  • Must be able to perform the essential functions of the job, with or without reasonable accommodations.
  • Must have ability to respond to common inquiries or complaints from customers.
  • Must have intermediate PC skills including email, routine database activity, word processing, spreadsheets, graphics, etc. Must be familiar with various Microsoft Office products.
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Confirmed 9 hours ago. Posted 30+ days ago.

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