L7 Informatics · 2 weeks ago
Quality Compliance Specialist
Austin, TX
Full-time
Onsite
Entry, Mid LevelL7 Informatics is dedicated to transforming scientific processes and data management in the life sciences and healthcare sectors. The Quality Compliance Specialist will support and enhance the quality management system, ensuring compliance with standards and participating in audits and quality processes.
Big DataBiotechnologyGeneticsLife ScienceSaaSSoftware
Responsibilities
Support and participate in L7’s quality management system (QMS) by complying with the Quality Policy and SOPs, and by meeting L7’s QMS objectives
Participate in the ISO 9001:2015 project to certify L7’s QMS
Participate in internal and external audits, including preparation activities and training of internal auditors
Perform job functions in compliance with QMS requirements
Perform document control functions, including use of ZenQMS (L7’s eQMS)
Actively participate in QMS processes (e.g., document control, change control, nonconformances, audits, corrective and preventive actions, etc.)
Generate records as required by the QMS processes (e.g., Design History Files)
Ensure records are compliant with QMS requirements
Maintain metrics for QMS-related quality objectives
Create, review, and update Standard Operating Procedures (SOPs), Plans, and Policies to align with current and best practices
Perform presentations to L7 team members regarding QMS-related topics
Provide suggestions for continuous improvements to the QMS
Represent the QMS team at meetings
Collaborate with L7 team members at all levels to:
Advise on quality-related issues
Provide training
Create, review, and update software development life cycle (SDLC) documentation
Support implementation of preventive and corrective actions
Ensure records are compliant with QMS requirements
Assist with QA efforts, such as testing, as needed
Support on QMS-related tasks (e.g., supplier qualification, software validation, etc.)
Other duties and special projects as assigned
Qualification
Required
Bachelor's degree in technical field, English/literature, or a related field
Strong knowledge of, or experience with, a quality management system processes (e.g., document control, change control, nonconformances, audits, corrective and preventive actions, etc.)
Ability to consistently meet deadlines
Ability to thrive in a fast-paced, deadline-driven environment
Ability to work independently with minimal supervision
Ability to handle multiple projects simultaneously
Strong verbal and written communication skills
Strong collaboration skills to work with team members at all levels
Preferred
Experience authoring technical documentation in a regulated environment
Company
L7 Informatics
L7 Informatics provides a unified platform, L7|ESP®, that contextualizes data and eliminates business silos via process orchestration.
Founded in 2011
51-200 employees
H1B Sponsorship
L7 Informatics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2021 (1)
Funding
Current Stage
Growth StageTotal Funding
$62.06MKey Investors
Banneker PartnersPhoenix Venture Partners
2022-06-07Series C· $38M
2021-03-08Series B· $13M
2019-12-02Series A· $4.59M
Leadership Team
John Neale
Chief Financial Officer
Vasu Rangadass
Founder
Recent News
Company data provided by crunchbase