Quality Specialist

Overview

Lightship is the virtual-first provider that is perfecting the way clinical trials get done. Because clinical research plays such a vital role in bringing life-enhancing and lifesaving innovations to market, Lightship pursues operational excellence in clinical studies. Our end-to-end hybrid delivery model, our diversity of skillsets, and in-house care team ensure sponsor success and the best possible patient experience. With a problem-solving mindset, we strive to make every clinical trial better than the last. Operational excellence is not a goal, but a way of doing things at Lightship.

The Quality Specialist is an experienced quality assurance professional who is process driven. This individual possesses an ability to successfully implement and maintain efficient quality systems. The Quality Specialist works in a pivotal role maintaining Lightship’s comprehensive quality management system. This individual will engage with cross functional resources to ensure that all quality standards are being met and maintained. 

Given the distributed team model at Lightship, and the remote nature of this position, individuals must possess a willingness and desire to work independently without significant oversight. Additionally, this position may require mild travel – approximately 10%. 

The Quality Specialist is responsible for:

• Participating in the management of the comprehensive quality management system at Lightship 

• Acting as the business process owner for Lightship’s electronic document management system (eDMS), quality management system (QMS) and learning management system (LMS) by providing operational and administrative support and ongoing training to end user 

• Identifying and assessing the training needs of the organization and administering company and GCP training 

• Assisting in the preparation for Quality Management Reviews (QMR), including compiling and reviewing relevant quality key performance indicators (KPIs) and participating in the execution of QMRs 

• Supporting internal audits of GCP functional areas, client audits and/or regulatory inspections by running the audit/inspection support room (e.g., retrieve records upon request, manage Slack (or similar) channel, maintain daily logs of document request) as required 

• Assisting in vendor qualification and re-qualification, including supporting with the preparation and execution of vendor audits  
  
• Contributing to the review and management of deviation investigations and Corrective and Preventive Actions (CAPAs) and Effectiveness Checks (ECs)
  
•  Contributing to the creation and maintenance of quality related SOPs, policies, and related training 

• Acting as a Quality SME in cross-functional process improvement activities 

• Review and approve computerized system validation deliverables including but not limited to Change Control Records, Validation Documents, Requirements Risk assessment, User Requirements, Part 11 Assessments, etc.  

• Other duties as assigned 

The Quality Specialist has:

• Required knowledge, skills, and abilities:

  • Excellent oral and written communication skills 

  • Thorough knowledge of International Conference on Harmonization (ICH) / Good Clinical Practice (GCP) guidelines and regulations 
    
  • Ability to work cross functionally
    
  • Ability to prioritize and successfully manage multiple tasks 
    
  • Ability to maintain flexibility and to adapt in a fast-paced environment
    
  • Exceptional attention to detail 
    
  • Superior time management and organizational skills 
    
  • Web and computer skills, including advanced knowledge of Microsoft Office Suite
     

• Education and experience:

  • Bachelor’s degree in Life Science/healthcare 

  • 2+ years of experience in a quality assurance function or equivalent experience in a role with quality and/or compliance responsibilities  
    
  • 2+ years of experience within clinical research, biologic, biopharmaceutical, or regulated pharmaceutical industry 
    
  • Previous experience using and/or managing an electronic document management system/quality management system, MasterControl experience preferred 
    
  • Requisite combination of education, training, and experience 

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 virtual-first clinical research solutions at scale.
• An unmatched opportunity to grow as part of an established startup with industry veterans, high-caliber investors, and a massive market opportunity.
• Great compensation

Generous benefits package, including:

• Top notch healthcare (medical, dental, and vision) for you and your family.
• 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.
• A home office stipend to set yourself up for success in our distributed working environment
• Company provided laptop, your choice of a PC or a Mac
• Monthly stipend for internet and phone expenses
• Generous paid parental leave
• Short & long-term disability
• Life insurance and More!

The base salary range for this role is between $82,000 and $100,000, depending on education, skills, and experience.  To determine our compensation, we use a market-based approach that is geographically neutral. We believe that this demonstrates our company value of ‘believing in people’ – valuing the outputs and performance of each team member.

Please note: For the safety of our patients and each other, all positions at Lightship that require travel, in-person participation, or are patient-facing, do require vaccination against COVID-19.

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

Lightship is an E-Verify employer. Find out more here: Right to Work Poster E-Verify Participation Poster

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