Overview

Lightship is the premier provider of enterprise level, technology enabled direct-to-patient clinical research. In this capacity, Lightship functions as a telemedicine-enabled site within a research study, which makes research participation possible for patients through the use of technology and home visits by our nurses.

Lightship is seeking an experienced quality assurance professional to join our team as a Quality Associate. This individual is process-minded and possesses an ability to successfully implement and maintain efficient quality systems. The Quality Associate works in a pivotal role maintaining Lightship’s comprehensive quality management system.

This position is remote, and a successful candidate will possess a willingness and desire to work independently without significant oversight. Additionally, this position may require some travel.

We would like to offer you:

  • An opportunity to help re-envision how clinical research is executed with inclusivity, increased diversity and accessible at the core
  • The chance to work with a patient-centered, clinically-oriented, collaborative team to support in the delivery of enterprise grade direct-to-patient clinical research solutions at scale
  • An unmatched opportunity to grow as part of an early stage startup with industry veterans, high-caliber investors, and a massive market opportunity
  • Competitive compensation

Generous benefits package, including:

  • Top notch healthcare (medical, dental, and vision) for you and your family, effective on day one of employment.
  • Unlimited Paid Time Off (PTO), plus paid holidays and bereavement to help support work life balance.
  • A 100% 401(k) company match for up to 4% of eligible contributions with an immediate vesting.
  • Generous paid parental leave
  • Short & long-term disability
  • Life insurance and More!

 

You will be responsible for:

  • Participating in the management of the comprehensive quality management system at Lightship.
  • Participating in the implementation and administration of Lightship’s electronic document management system (eDMS) and quality management system (QMS).
  • Assisting in the management of controlled documents across Lightship.
  • Assisting in the preparation for Quality Management Reviews, including compiling and reviewing relevant quality key performance indicators (KPIs).
  • Participating in internal audits of GCP functional areas as designated.
  • Participating in client audits and regulatory inspections as a subject matter expert, host, and / or running the “war room” as required.
  • Participating in review and management of investigations, deviations, and CAPA.
  • Other duties as assigned.

Required Qualifications:

  • Strong communication skills including written and verbal
  • Knowledge of ICH /GCP guidelines and regulations
  • Ability to work with cross functionally and multitask
  • Maintain flexibility or have the ability to adapt in a fast-paced environment
  • Exceptional attention to detail
  • Time management and organizational skills
  • Strong computer skills including but not limited to Microsoft Office
  • 2+ years in Quality Assurance/Quality Control function
  • 4+ years’ experience within the biologic, biopharmaceutical, or regulated pharmaceutical industry.
  • Bachelor’s degree in Life Science or healthcare related field

 

Preferred qualifications:

  • Previous experience using the electronic document management system/quality management system, MasterControl
  • Previous remote work experience

 

Our commitment to diversity & inclusion:

Lightship is an equal opportunity employer and promotes a diverse and inclusive workplace. Lightship considers all applicants without regard to race, color, religion, creed, national origin, age, sex, marital status, ancestry, disability, veteran status, gender identity, genetic information, sexual orientation, or any other status protected by applicable law.  EEO is the Law

#jobs #careers #nowhiring #hiringnow 

 

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