QMS Analyst

<QMS Analyst>

<US-Remote>

EGNYTE YOUR CAREER. SPARK YOUR PASSION.

Egnyte is a place where we spark opportunities for amazing people. We believe that every role has a great impact, and every Egnyter should be respected. When joining Egnyte, you’re not just landing a new career, you become part of a team of Egnyters that are doers, thinkers, and collaborators who embrace and live by our values:

Invested Relationships

Fiscal Prudence

Candid Conversations

ABOUT EGNYTE

Egnyte is the secure multi-cloud platform for content security and governance that enables organizations to better protect and collaborate on their most valuable content. Established in 2008, Egnyte has democratized cloud content security for more than 22,000 organizations, helping customers improve data security, maintain compliance, prevent and detect ransomware threats, and boost employee productivity on any app, any cloud, anywhere. For more information, visit www.egnyte.com.

Our GxP Quality Assurance team enables Egnyte and our customers to have confidence in our platform when used to support GxP operations.  The team is responsible for the design and maintenance of a GxP compliant Quality Management System and Egnyte’s GxP Computer Software Assurance Program.  Egnyte is taking exciting steps forward to bring Generative AI to our GxP platform and you accordingly will help develop the future direction of computer system assurance standards in the industry.

WHAT YOU’LL DO:

• Reports to the Head of GxP Quality Assurance
• Serves as an Administrator of the electronic Quality Document Management System.
• Develops and maintains Quality System procedures (e.g., SOPS, Work Instructions, etc.) in conjunction with Business Owners and Subject Matter Experts and in keeping with applicable GxP regulatory requirements.
• Ensures that the Egnyte Quality System procedures meet or exceed applicable regulatory requirements and industry quality expectations for the products and services Egnyte provides.
• Participate in the development of training on Quality System topics and delivery of the training across the organization.
• Provide support for both internal and external quality system audits including hosting customer audits and providing audit responses.
• Assists management with the tracking of observations result from audits conducted both internally and externally.
• Develops corrective and preventative action (CAPA) plans for QMS issues.
• Collaborates closely with Product Development and Validation experts to understand product changes and conduct a risk assessment of those changes to the validated state of the system.
• Apply GxP compliance understanding to new features proposed by development and determine validation requirements.
• Review Validation documentation such as Validation Plans, Traceability Matrices, Test Cases, Test Execution, and Validation Summaries.
• Conducts Installation verification of customer systems.
• Drafts for review customer communications.

YOUR QUALIFICATIONS:

• 3+ years of experience in Quality Assurance and managing QMS frameworks in a GxP regulatory environment.
• Has previously developed Training materials is a plus.
• Experience in the conduct of GxP audits minimally observing and preferrable hosted.
• Understanding of Computer Software validation procedures.
• Basic knowledge of GxP regulations such as ICH E6 and 21 CFR part 11.
• Demonstrates excellent personal communication skills both written and verbal.

COMPENSATION:

• Our compensation reflects the cost of labor across multiple U.S. geographic locations, and pay varies based on defined markets. The standard base pay range for this position across the U.S. is $99k - $130k annually. Pay varies by work location and may also be dependent on job-related skills, knowledge, and/or experience. During the interview and/or hiring process, your recruiter can share more information about the compensation package specific to the role and job location.

BENEFITS:

• Competitive salaries and comprehensive benefits
• Company equity depending on role and level
• Flexible hours and generous time off (RTO, Responsible Time Off) to help support your work-life balance
• Paid holidays and sick time
• 401(k) Retirement Plan (Traditional, Roth and Mega Backdoor Roth)
• Health Savings Account (HSA) with a generous employer contribution
• Up to 12wks of paid Parental and Adoption Leave to help you grow your family
• Modern and collaborative offices located in Spokane, WA; Draper, UT; Raleigh, NC; Mountain View, CA; Reading, England, and Poznan, Poland
• Gym, cell phone, and internet reimbursement
• Free well-being apps such as Peloton, Carrot, and Spring Health for Guardian are offered, as well access to our Employee Assistance Program (EAP)
• Perks include discounted pet insurance, electronics, theme park tickets, travel, plus more
• Your own Egnyte account with lifetime access

Equal Employment Opportunity

Egnyte, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Egnyte, Inc.'s management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment.

Commitment To Diversity, Equity, and Inclusion:

At Egnyte, we celebrate our differences and thrive on our diversity for our employees, our products, our customers, our investors, and our communities. Our global Egnyte Employee Communities (EECs) support representation and inclusion across our diverse workplace. Egnyters are encouraged to bring their whole selves to work and to appreciate the many differences that collectively make Egnyte a higher-performing company and a great place to be.

Any employees with questions or concerns about equal employment opportunities in the workplace are encouraged to bring these issues to the attention of [email protected]. Egnyte, Inc. will not allow any form of retaliation against employees who raise issues of equal employment opportunity. If employees feel they have been subjected to any such retaliation, they should contact [email protected]. To ensure the workplace is free of artificial barriers, violation of this policy including any improper retaliatory conduct will lead to discipline, up to and including discharge. All employees must cooperate with all investigations conducted pursuant to this policy.