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Senior Specialist, Quality Assurance – Drug Substance
<meta><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;"=""><b><strong style="font-size:15pt;white-space:pre-wrap;">About the role</strong></b></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;"=""><span style="white-space:pre-wrap;">The Senior Specialist, Quality Assurance – Drug Substance is responsible for executing quality assurance activities that support clinical and commercial manufacturing of drug substance in compliance with cGMP standards. This role focuses on batch record review, vendor oversight support, and ensuring the accuracy and completeness of GMP documentation across internal and external manufacturing operations. The individual will work closely with contract manufacturers and other drug substance CMOs, to support tech transfer, process validation, and routine GMP operations. Success in this role requires strong attention to detail, the ability to manage multiple priorities, and effective cross-functional collaboration to ensure timely batch disposition and compliance. The position operates as a key contributor within the Commercial QA team, supporting inspection readiness and continuous improvement of quality systems.</span></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;"=""><b><strong style="color:rgb(0,0,0);background-color:rgb(255,255,255);font-size:15pt;white-space:pre-wrap;"> </strong></b><b><strong style="font-size:15pt;white-space:pre-wrap;">Location: </strong></b><span style="white-space:pre-wrap;">Remote</span></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;"=""><br></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;"=""><b><strong style="font-size:15pt;white-space:pre-wrap;">Essential Functions</strong></b></p><ul data-pattern="discCircleSquare" data-depth="1" style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11pt;font-weight:400;margin:8px="" 0px;line-height:1.6;padding:0px="" 0px="" 32px;list-style-type:disc;"=""><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">QA Systems Execution & SOP Support: Support the implementation, revision, and maintenance of QA programs, policies, and procedures to ensure compliance with cGMP, FDA, and ICH requirements. Assist in updating SOPs to mitigate compliance gaps and support commercial QA readiness.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Tech Transfer & Process Validation Support: Support QA activities related to drug substance tech transfer, process performance qualification (PPQ), and preparation for process validation activities. Ensure QA compliance of validation protocols, reports, and associated GMP documentation during execution.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Batch Record Review & GMP Disposition Support: Perform QA review of batch production records, validation data, deviation investigations, and analytical documentation associated with drug substance manufacturing to ensure accuracy, completeness, and compliance with GMP standards. Support timely disposition activities once all required data is available.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Vendor QA Oversight Support: Serve as a QA point of contact for assigned contract manufacturers and partners by supporting QA oversight activities, including participation in manufacturing, validation, and change management processes to ensure GMP compliance.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">GMP Auditing & Inspection Readiness: Support and participate in GMP audits for vendor qualification or requalification (minimum of two), including preparation, execution support, and documentation of findings. Assist in maintaining inspection readiness for internal and external stakeholders.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Documentation & Analytical Review: Perform QA review of manufacturing, validation, and analytical documents related to API/drug substance release testing, stability programs, raw materials, intermediates, and analytical method qualification/validation to ensure compliance with regulatory expectations.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Quality Event Management Support: Support the review and resolution of quality system events, including deviations, CAPAs, change controls, and out-of-specification investigations. Ensure proper documentation and timely follow-up to support effective closure.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Cross-Functional Collaboration & Continuous Improvement: Collaborate with internal teams and external partners to ensure QA requirements are met across manufacturing and quality processes. Identify and support improvements to QA systems, documentation workflows, and compliance processes.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Additional Responsibilities: Perform other QA-related duties as assigned to support the Commercial Quality Assurance organization.</span></li></ul><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;"=""><b><strong style="font-size:15pt;white-space:pre-wrap;">Qualifications</strong></b></p><ul data-pattern="discCircleSquare" data-depth="1" style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11pt;font-weight:400;margin:8px="" 0px;line-height:1.6;padding:0px="" 0px="" 32px;list-style-type:disc;"=""><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Bachelor’s degree (BS/BA) in a relevant scientific discipline (e.g., Biology, Chemistry, Pharmaceutical Sciences, or related field).</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Minimum of four to six (4–6) years of experience in Quality Assurance and/or Quality Systems within the biotechnology or pharmaceutical industry.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Direct experience supporting GMP-regulated drug substance/API manufacturing, including batch record review, process validation support, and documentation compliance.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Experience supporting contract manufacturing organizations (CMOs) or external vendors in a QA capacity.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Hands-on experience with quality systems such as deviations, CAPAs, change control, and/or OOS investigations.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Working knowledge of cGMP regulations, FDA guidelines, ICH standards, and industry best practices related to drug substance/API manufacturing and process validation.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Ability to review and interpret technical documentation (batch records, validation protocols/reports, analytical data). • Strong organizational skills with the ability to manage multiple priorities and meet deadlines.</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Proficiency with electronic quality systems and document management platforms. </span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">Ability to travel domestically and internationally (~20%) as needed.</span></li></ul><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;text-align:start;"=""><u><i><b><strong style="text-decoration:underline;font-style:italic;white-space:pre-wrap;">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.</strong></b></i></u></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;text-align:start;"=""><br></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;text-align:start;"=""><b><strong style="font-size:15pt;white-space:pre-wrap;">Total Rewards</strong></b></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;text-align:start;"=""><span style="white-space:pre-wrap;">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.</span></p><ul data-pattern="discCircleSquare" data-depth="1" style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11pt;font-weight:400;margin:8px="" 0px;line-height:1.6;padding:0px="" 0px="" 32px;list-style-type:disc;"=""><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">HIGHLY COMPETITIVE SALARIES </span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">ANNUAL PERFORMANCE/MERIT REVIEWS</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">ANNUAL PERFORMANCE BONUSES</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">EQUITY</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">SPECIAL RECOGNITION</span></li></ul><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;text-align:start;"=""><b><strong style="font-size:15pt;white-space:pre-wrap;">Well-Being Benefits</strong></b></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;text-align:start;"=""><span style="white-space:pre-wrap;">In addition to our Total Rewards, CG Oncology offers a variety of Well-Being Benefits to meet the majority 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.</span></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;text-align:start;"=""><span style="white-space:pre-wrap;">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.</span></p><ul data-pattern="discCircleSquare" data-depth="1" style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11pt;font-weight:400;margin:8px="" 0px;line-height:1.6;padding:0px="" 0px="" 32px;list-style-type:disc;"=""><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">FULLY REMOTE WORK ENVIRONMENT</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">REST AND RECHARGE BENEFITS - Unlimited Flexible Time Off</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">HOLIDAYS –In 2026 we will observe 14 holidays</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">RETIREMENT – 401K with 100% company Safe Harbor match up to 4% of base salary</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">HEALTH (MEDICAL, DENTAL, VISION) – PPO & HDHP – Cigna/Principal</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">HEALTH SPENDING ACCOUNTS - HSA (with Annual Company Contribution), FSA, FSA-DC</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">ILLNESS & DISABILITY PROTECTION – Company Paid LTD Coverage + Voluntary Plans</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">LIFE INSURANCE – Company Paid 1 x base salary + Voluntary Plans</span></li><li style="font-size:11pt;margin:3px 0px;letter-spacing:0.25px;line-height:1.6;"><span style="white-space:pre-wrap;">ADDITIONAL EXCLUSIVE BENEFITS – Voluntary Legal, Pet, Plus More</span></li></ul><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;text-align:start;"=""><span style="white-space:pre-wrap;"> </span></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;text-align:start;"=""><b><strong style="white-space:pre-wrap;">CG Oncology is an Equal Opportunity Employer</strong></b><span style="white-space:pre-wrap;">:</span></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;text-align:start;"=""><span style="white-space:pre-wrap;">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.</span></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;text-align:start;"=""><span style="white-space:pre-wrap;"> </span></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;text-align:start;"=""><br></p><p style="font-family:" basel="" grotesk",arial,sans-serif;font-size:11.25pt;font-weight:400;line-height:1.6;letter-spacing:0.25px;margin:4px="" 0px;padding:0px;text-align:start;"=""><br></p>