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Full-Time

Quality Operations Specialist

Posted on 8/23/2024

Fullscript

Fullscript

201-500 employees

Platform for managing supplement plans

Healthcare
Consumer Goods

Compensation Overview

$45k - $65kAnnually

Senior, Expert

Riverside, CA, USA

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary
Required Skills
Communications
PowerPoint/Keynote/Slides
Requirements
  • +5 years of quality experience within a regulated industry, e.g., food, dietary supplement, drug, or medical device industries.
  • A thorough understanding of cGMP requirements.
  • Meticulous attention to detail, superior organizational capabilities, and a keen investigative approach are crucial.
  • Proactive self-starter with the ability to concentrate and drive tasks to completion autonomously.
  • Exceptional verbal and written communication skills are required for effective dissemination of information and collaboration with colleagues across all organizational levels, as well as potential interactions with regulatory agencies.
  • Proficiency in Microsoft Office applications and /or Google Suites, including Word, Excel, and PowerPoint.
  • Familiarity with WMS / ERP systems will be preferred.
  • Ability to work independently within a warehouse environment.
Responsibilities
  • Maintain sanitation, hygiene, and housekeeping program of the distribution center to meet cGMP and regulatory requirements.
  • Perform regular DC inspections and follow-up actions to correct and prevent non-conforming issues, and escalating concerns to the Quality Operations Manager as needed.
  • Ensure that sanitation, hygiene, and housekeeping procedures and records are adequate and suitably maintained.
  • Ensure that temperature / RH controls of the distribution center meet cGMP and regulatory requirements and that temperature / RH procedures and records are adequate and suitably maintained.
  • Coordinate pest control activities for the distribution center to ensure compliance with cGMP and regulatory requirements.
  • Maintain pest control procedures and records.
  • Oversee product returns and product disposition decisions at the distribution center(s) to ensure compliance with established requirements and timely and effective handling.
  • Ensure that product returns & disposition procedures are records are adequate and suitably maintained.
  • Ensure that environmental controls of the distribution center meet cGMP and regulatory requirements.
  • Maintain environmental control procedures and records.
  • Oversee the preventive maintenance and calibration program to ensure that all critical equipment that may affect the quality and safety of the product is suitably maintained to meet established requirements.
  • Maintain preventive maintenance procedures and records.
  • Provide cGMP and cGDP training for new hires and refresher training annually for all distribution center employees, and ensure completion of training records.
  • Assist employees with understanding quality assurance policies and cGMP procedures.
  • Support external quality / regulatory audits.
  • Working closely with distribution center management and quality management to ensure site readiness, coordinate documentation / record availability, and ensure a suitable facility environment to support successful audits.
  • Perform internal quality audits and / or product verification audits as per internal audit procedure requirements.
  • Complete internal audit reports and follow-up on non-conforming issues to drive correction and prevention of issues and escalate concerns to the Quality Operations Manager as needed.
  • Support product recalls, product quarantine directives, and customer complaint activities as needed.
  • Support system verification and validation activities as needed.
  • Additional quality-related duties may be assigned as needed.

Fullscript provides a platform for healthcare practitioners to create and manage supplement plans for their patients. The platform allows practitioners, such as doctors and nutritionists, to personalize treatment plans with custom protocols and features. It simplifies the workflow for health practitioners and aims to improve patient outcomes by offering tools, education, and reminders that support behavior change. Fullscript operates in a two-sided market, selling high-quality supplements directly to patients or in-office, with prices set by the practitioners to make wellness more affordable. Additionally, the company offers educational resources, including infographics and articles, to help patients adhere to their supplement plans. Fullscript's goal is to enhance the relationship between health practitioners and patients while promoting better health through personalized supplement strategies.

Company Stage

Series B

Total Funding

$273.1M

Headquarters

Ottawa, Canada

Founded

2011

Growth & Insights
Headcount

6 month growth

4%

1 year growth

8%

2 year growth

10%
Simplify Jobs

Simplify's Take

What believers are saying

  • The addition of experienced leaders like Ashley Koch and Aimee Miller to the executive team and board signals strong strategic direction and governance.
  • Partnerships with established healthcare entities and digital wellness platforms, such as athenahealth and Flöka, enhance Fullscript's credibility and market reach.
  • The acquisition of Emerson Ecologics positions Fullscript for accelerated growth and greater influence in the integrative medicine sector.

What critics are saying

  • The wellness and supplement industry is highly competitive, requiring continuous innovation to maintain market leadership.
  • Integration challenges from acquisitions, such as Emerson Ecologics, could divert focus and resources, potentially impacting service quality.

What makes Fullscript unique

  • Fullscript's platform uniquely integrates supplement management with educational resources, setting it apart from competitors who may only focus on product sales.
  • The company's two-sided market approach, serving both practitioners and patients, creates a comprehensive ecosystem that enhances patient adherence and outcomes.
  • Fullscript's partnerships with major healthcare platforms like athenahealth and acquisitions like Emerson Ecologics bolster its market position and expand its service offerings.
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