Apothecary Products

  • Quality System Specialist

    Job Locations US-MN-Burnsville
    Posted Date 3 weeks ago(3 weeks ago)
    Category
    Quality/Regulatory
    FLSA Status
    Exempt
    Type
    Regular Full-Time
  • Overview

    Apothecary Products (APL) is currently seeking a Quality System Specialist to join our team. The Quality System Specialist provides tactical direction and hands-on support in the development, implementation and maintenance of the company’s Quality Management System (QMS) to demonstrate compliance with all applicable regulatory and quality systems requirements. This role will administer many systems as they relate to the QMS in addition to performing training and management reviews. Supports Regulatory Affairs and continual improvement initiatives and training. 

    Responsibilities

    In this role the incumbent will:

    • Performs critical analysis of quality systems metrics to identify any patterns or trends that may need corrective action. Presents critical analysis of quality metrics, along with conclusions and recommendations at operational QMS management reviews.
    • Coordination of internal quality audits and regulatory audits and inspections.
    • Determines inspection criteria, creates function test methods, establishes the inspection criteria and sampling plans, and performs inspections to ensure products meet specified requirements and customer expectations.
    • Coordinates product testing to meet regulatory and customer specification/contractual requirements.
    • Coordinates the investigation of product issues reported by the customer, performs trend analysis, and works with other company function as necessary to identify/implements effective solutions and corrective and preventive actions.

    Qualifications

    We seek applicants with these critical skills and experience:

    • A bachelor’s degree in a technical discipline is preferred.
    • 3 years of work experience in a regulated environment that includes the key aspects of a quality management system.
    • Experience in FDA regulations and ISO compliant systems standards applicable to consumer products and medical devices, including 21 CFR 820 and ISO 13485.
    • Strong understanding of quality related principles and techniques (corrective and preventative actions, document control, continual improvement, statistical analysis and root cause analysis).
    • Internal auditing experiences: ASQ certification a plus.

    Click here for a complete job description. 

     

    The Company – Why APL:

    APL is a leading innovator, manufacturer, marketer and supplier of simple self-care solutions, pharmacy supplies and wellness aids. We are based in Burnsville, MN with several manufacturing and vendor partners in the US and internationally.  APL has pioneered many strong consumer product categories, including medication management – in fact, our original owner invented the pill box! We have many trusted brands in the marketplace and do business with well-known mass retailers, grocery and chain drug stores. We’ve also got a great culture embedded in our WE CARE values that helps ensure we have a lot of fun each day and are a high-performing work team.

     

    The Rewards - What We Offer:

    The rewards we provide recognize and retain collaborative, results-oriented, strong contributors. Our comprehensive programs support team members and their families in their efforts to live healthy lives. We strive to create opportunities for career growth and financial success – all while being an agile employer committed to open communication. Rewards include:

    • Annual incentive program
    • Team member and family insurance programs including employer contributions, including, medical, dental, life, AD&D, short-term and long-term disability
    • Vision, pet, legal, accident and critical illness insurance programs
    • Financial wellness benefits including savings account and for health and dependent care expenses and 401k
    • Discount and employee assistance programs
    • Work/life blend: 9 paid holidays and time off starting at 3 weeks plus summer hours and paid volunteer time
    • Onsite wellness activities including on-site community garden, yoga, volleyball, and walking clubs
    • Community giveback opportunities supporting local and national charities
    • Casual dress every day of the week, food trucks and many team activities

    Interested – How to Apply:

    Learn more and apply at www.apothecaryproducts.com

     

    Posted: 9-6-2018

    EOE/M/F/Vet/Disability. No agency calls at this time.

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