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QA SPECIALIST, Document Control (GXP)

CG Oncology

CG Oncology

Quality Assurance
Remote
Posted on Wednesday, June 5, 2024

Are you ready to make a difference in the world and become part of our patient-centered team that is focused on Attacking Bladder Cancer for a Better Tomorrow? At CG Oncology, we believe that by having exceptionally talented individuals on our team who share our passion and enjoy working together, we can truly achieve our Vision and Mission to benefit patients around the world.

Every day we are making significant advancements across our multiple pipelines and are growing rapidly to meet the needs of our patients who cannot afford to wait to benefit from our novel immunotherapies. Please review this job posting and our Values and if they resonate with you and are what you expect from your organization and team, then we would like to hear from you.

We invite you to review our website to learn more about our company and team by visiting our website at https://www.cgoncology.com/careers/#overview.

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Role: QA Specialist (GXP)

Location: Remote US-Based

Essential Functions:

  • Review, route, and archive Controlled Documents (Standard Operating Procedures, Work Instructions, Protocols, Reports, Batch records, data and data summary tables, and clinical trial documentation in accordance with applicable GxP regulations, OECD, and ICH guidelines, as well as corporate policies and standard operating procedures (SOPs).
  • Scans, verifies, and archives documentation and records, as needed. • Interact with internal department managers (not limited to: CMC, Regulatory, Clinical) to resolve questions, gap analysis deficiencies and/or compliance issues.
  • Provide excellent verbal/email communication and presentation skills to external GxP vendors as necessary to achieve required QA deliverables and project requirements.
  • Participate in the administration of the company’s GxP Quality Systems (not limited to: Document Control System and Training Program).
  • Will manage and facilitate Document Control system including revising company’s GxP SOPs and related documents and implementation of system improvements, as needed.
  • Provides support in document processing and formatting in compliance with company standards.
  • Monitor and analyze document control metrics to enhance efficiency and compliance, reporting to Management as necessary.
  • Assist QA Management with departmental needs.
  • Able to prioritize and manage several projects and activities simultaneously.
  • Working knowledge of validated electronic systems, including but not limited to: Document Control, Training Management, QMS.

Qualifications:

  • BS/BA in a relevant scientific discipline; experience may substitute for minimum educational requirements
  • Minimum three (3) years of related experience in Quality Systems and Quality Assurance processes, development, and documentation.
  • Minimum one (1) year of related experience at a specialist level.
  • Veeeva experience preferred or strong administrator skills of similar systems

The U.S. target annual salary range for this remote, full-time, position is currently set at $95,000-$110,000 The actual base salary offered for this role will vary depending on job-related knowledge, skills, market factors, experience and considering internal equity. In addition, to the base salary, CG Oncology offers a very attractive set of Total Rewards (including bonus and equity) and Well-Being Benefits provided as part of the overall compensation package for this role.

Please visit https://www.cgoncology.com/careers/#rewards for a listing of these rewards and benefits.

Total Rewards

CG Oncology offers very competitive and comprehensive Total Rewards, helping to support and reward our global team of high-performing employees focused on developing bladder-saving therapeutics for patients afflicted with bladder cancer.

  • HIGHLY COMPETITIVE SALARIES
  • ANNUAL PERFORMANCE/MERIT REVIEWS
  • ANNUAL PERFORMANCE BONUSES
  • EQUITY
  • SPECIAL RECOGNITION

Well-Being Benefits

In addition to our Total Rewards, CG Oncology offers a variety of Well-Being Benefits to meet most of the needs of our unique and growing workforce. These benefits are designed to support our team to achieve a healthy balance between work and their personal lives to remain refreshed, engaged, and creating an environment where each person can find a deeper meaning and purpose in their work.

Well-Being Benefits eligibility begins the 1st of the month after hire. While a majority of these benefits are for our US-based workforce, we continue to assess comparable levels of benefits for our international team members that are aligned with country-specific regulations and their national programs offered.

  • FULLY REMOTE WORK ENVIRONMENT
  • REST AND RECHARGE BENEFITS - Unlimited Flexible Time Off
  • HOLIDAYS – We observe 12 Holidays/year
  • RETIREMENT – 401K with 100% company Safe Harbor match up to 4% of base salary
  • HEALTH (MEDICAL, DENTAL, VISION) – HMOs, PPOs & HDHP – Anthem/MetLife
  • HEALTH SPENDING ACCOUNTS - HSA (with Annual Company Contribution), FSA, FSA-DC
  • ILLNESS & DISABILITY PROTECTION – Company Paid LTD Coverage + Voluntary Plans
  • LIFE INSURANCE – Company Paid 1 x base salary + Voluntary Plans
  • ADDITIONAL EXCLUSIVE BENEFITS – Voluntary Legal, Pet, Plus More

CG Oncology is an Equal Opportunity Employer:

All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status. At CG Oncology, we are building a community of intelligent and passionate team members that share our Vision, Mission, and Values, and while the biotechnology space can feel limited in BIPOC, non-binary and even female representation, we endeavor to make hiring decisions that will continue to grow and support our team in the direction of maintaining cultural diversity and sustainability.

Please note that CG Oncology does not accept unsolicited information and/or resumes from search firms or agencies for our job postings. Any resumes or client information submitted to our careers page or any employee of CG Oncology by any search firm or agency without an applicable contract in place will become the property of CG Oncology and no fee(s) will be paid.