Full-Time

Quality Operations Specialist

Posted on 9/10/2024

Fullscript

Fullscript

501-1,000 employees

Platform for managing supplement plans

Education
Healthcare
Consumer Goods

Compensation Overview

$45k - $65kAnnually

Senior, Expert

Riverside, CA, USA

This position requires candidates to be located in Riverside, California, as it is an onsite role.

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 simplifies the workflow for health professionals, allowing them to personalize treatment plans with custom protocols and features. It serves over 70,000 practitioners, including doctors and nutritionists, and operates in a two-sided market by selling high-quality supplements directly to patients or in-office, with prices set by the practitioners. Fullscript also offers educational resources to help patients adhere to their supplement plans, including infographics, handouts, and an award-winning blog covering various wellness topics. The company's goal is to improve patient outcomes and make wellness more affordable through effective supplement management.

Company Stage

Late Stage VC

Total Funding

$265.7M

Headquarters

Ottawa, Canada

Founded

2011

Growth & Insights
Headcount

6 month growth

-2%

1 year growth

-3%

2 year growth

-3%
Simplify Jobs

Simplify's Take

What believers are saying

  • The acquisition of Rupa Health expands Fullscript's comprehensive care platform.
  • Partnership with 3X4 Genetics enhances personalized supplement recommendations.
  • Growing demand for telehealth boosts Fullscript's digital health platform.

What critics are saying

  • Integration challenges with Rupa Health could lead to operational inefficiencies.
  • Regulatory scrutiny may arise from handling genetic data with 3X4 Genetics.
  • Recent executive changes could cause strategic misalignments during transitions.

What makes Fullscript unique

  • Fullscript offers a seamless blend of virtual dispensing and in-office sales.
  • The platform supports over 70,000 practitioners with personalized treatment plans.
  • Fullscript's educational resources enhance patient adherence and promote wellness.

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Benefits

Flexible Paid Time Off

Stock Options

Health Insurance

Dental Insurance

Vision Insurance

401(k) Company Match

Remote Work Options

Wellness Program

Training Budget

INACTIVE