Quality Compliance Specialist

L7 INFORMATICS INC•Austin, TX

About The Position

At L7 Informatics, Inc. [https://c212.net/c/link/?t=0&l=en&o=3289306-1&h=3106298868&u=https%253A%252F%252Fl7informatics.com%252F&a=L7+Informatics%252C+Inc.], our mission is to revolutionize scientific processes and data management to accelerate precision health across life sciences, healthcare, and nutrition value chains. Our end-to-end solutions and services enable researchers to make new genomics discoveries, precision therapeutics manufacturers to create higher fidelity therapies, health systems to provide superior diagnostics and standard of care, and precision agriculture to meet tomorrow's needs. The L7 culture is one of the biggest reasons why our people choose to stay. Our culture is driven by four core values: 1. Collaboration: Listen empathetically to customers and colleagues. Seek first to understand. Actively listen with an open mind. 2. Innovation: Inspire each other to think big, bring new ideas, imagine all possibilities. Maintain a safe to fail environment where all ideas are welcome & valued. Be vigilant in our pursuit of creative solutions. 3. Excel: Strive for excellence in all we do. Elevate expectations and performance with every opportunity. Provide "best in class" product, customer service, employee experience. 4. Growth: We recognize we don't know everything. Be courageous to ask the hard questions, give and receive respectful & actionable feedback. Invest in time for continuous learning and development. The most successful L7’ers are naturally persistent and resilient when it comes to solving problems and servicing our customers. They are full of grit, spunk and driven by our mission to make a positive impact on a very important industry that can improve healthcare for people around the world. Due to our continued growth, we are hiring a(n) Quality Compliance Specialist.

Requirements

Bachelor’s degree in technical field, English/literature, or a related field.
Experience authoring technical documentation in a regulated environment preferred.
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.

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.