Quality Assurance Manager

Job Description:
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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