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    Quality Manager - Waterbury, United States - Classic Westchester

    Classic Westchester
    Classic Westchester Waterbury, United States

    5 days ago

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    Description

    Job Title: Quality Management Specialist

    Company: QualityCare Inc.

    Responsibilities:

    • Develop, implement, and monitor various aspects of the site Quality Management System, including:
    • Site Internal Auditing program
    • Site CAPA program
    • Site Document Control program
    • Site Change Control program
    • Site Deviation Management program
    • Site Continuous Improvement program
    • Conduct trending of quality events

    • Communicate product issues and deviations to clients when necessary
    • Ensure high levels of internal and external customer service by responding to customer needs promptly
    • Respond to CAPAs (site, supplier quality, safety, audits, etc) as assigned
    • Revise or create standard operating procedures
    • Establish quality standards, objectives, and goals and communicate them to site personnel
    • Participate in and provide input for regular Quality Management Review Meeting discussions
    • Approval of specifications, sampling instructions, and test methods
    • Promote quality achievement and performance improvement organization-wide
    • Respond to any out-of-specification reports regarding site products
    • Ensure compliance with all relevant regulations and requirements
    • Write, review, and/or approve site validation protocols and summary reports
    • Conduct internal and supplier audits as needed
    • Prepare reports and data related to departmental objectives or requirements
    • Oversee hourly quality personnel including scheduling, performance reviews, disciplinary actions, hiring & firing

    Skills:

    • Self-starter mindset
    • Positive attitude
    • Able to work effectively in a fast-paced environment
    • Ability to create and interpret technical/analytical reports
    • In-depth knowledge of regulatory environment for OTC/FS manufacturing
    • Capacity to manage tasks in a matrix and interact successfully with diverse global and regional teams
    • Strong analytical, problem-solving, and decision-making abilities
    • Excellent verbal and written communication skills
    • Experience collaborating with multifunctional, regional, and global teams
    • Excellent communication and negotiation skills
    • Extensive working knowledge of relevant quality and regulatory standards and regulations
    • Background in risk management, validation, analytics, and microbiology within a GMP setting

    Requirements:

    • Must hold certification in food safety (SQF, HACCP, or equivalent)
    • Occasional domestic travel (<10%) may be required
    • Prior experience in managing teams
    • Able to sit/stand for extended periods (2 hours or more)
    • Capable of working in unconditioned environments (both hot and cold)
    • Must be able to wear company-issued protective equipment

    Qualifications:

    Education:
    Associate degree, plus 5 years of quality experience, including supervisory roles; or BS degree

    Experience:
    Minimum of 4 years of experience in a regulated environment with at least 2 years in supervisory positions
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