Apothecary Products

  • Quality Systems Specialist

    Job Locations US-MN-Burnsville
    Posted Date 2 weeks ago(2/6/2019 2:36 PM)
    Category
    Quality/Regulatory
    FLSA Status
    Exempt
    Type
    Regular Full-Time
  • Overview

    Apothecary Products (APL) is currently seeking a Quality Systems Specialist to join our team. The Quality Systems Specialist strategic and tactical direction, 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 and support critical QMS systems and processes including CAPA system, internal audits, product validation testing protocols, document and data control systems, and present management reviews. The incumbent will also support Regulatory Affairs, continual improvement initiatives, and other related duties as assigned.

     

    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.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.

     

    Responsibilities

    In this role the incumbent will:

    • Perform critical analysis of quality systems metrics to identify any patterns or trends that may need corrective action.
    • Present critical analysis of quality metrics, along with conclusions and recommendations at operational QMS management reviews.
    • Coordinate internal quality audits and regulatory audits and inspections.
    • Determine inspection criteria, create function test methods, establish the inspection criteria and sampling plans, and perform inspections to ensure products meet specified requirements and customer expectations.
    • Coordinate product testing to meet regulatory and customer specification/contractual requirements.
    • Assist with the investigation of product issues reported by the customer, perform trend analysis, and work with other company functions as necessary to identify/implements effective solutions and corrective and preventive actions.

     

    Click here for the full job description

    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.
    • Ability to develop and deploy practical and cost-effective quality system processes and procedures to align with business goals and objectives.
    • 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.

     

    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, discounts on products and employee assistance programs
    • Team member + family insurance programs including employer contributions: Medical, Dental, Life and AD&D, Short-term and Long-term Disability
    • Vision, Pet, Legal, and Identity Theft insurance programs
    • Financial wellness benefits including: Health Savings Account, Dependent Care Savings Account, and 401k
    • Work/life blend: 9 company-paid holidays, Paid Time Off starting at 3 weeks, paid Volunteer Time, and summer hours
    • Onsite wellness activities: on-site community garden, Yoga, Volleyball, and walking clubs
    • Community giveback opportunities supporting local and national charities
    • Relaxed work environment: 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: 2/6/2019

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

     

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