Celcuity · 1 day ago
Quality Assurance Coordinator
United States
Full-time
Remote
Mid Level
3+ years expCelcuity is a clinical-stage biotechnology company focused on developing targeted therapies for cancer treatment. They are seeking a Quality Assurance Coordinator to manage quality-related data and ensure compliance within the pharmaceutical division, including monitoring incidents and maintaining documentation.
BiotechnologyHealth CareHealth DiagnosticsTherapeutics
Responsibilities
Monitor the company’s dedicated inbox for Quality Incidents and potential issues and initiate processing in a timely manner
Maintain documentation that establishes tracking and oversight of Quality Incidents through resolution and/or closure
Maintain tracking information for the availability of inspection-ready documentation associated with staff qualification and training
Coordinate, oversee, and maintain documentation of GxP vendor risk assessment and qualification activities
Perform background checks on internal staff, vendors, and Celcuity research partners for FDA debarment, enforcement actions, and international regulatory restrictions or sanctions
Review documents, as assigned, for internal consistency and congruency with specified external standards as a compliance and data integrity check
Coordinate the development and revision of procedural documents governing QA activities, contributing to continual process improvement
Support the development of summary metrics for trending and for presentation to upper management and departmental heads
Participate in and support other areas of QA responsibilities as assigned and identified in the position summary
Conduct and/or oversee reviews of analytical protocols and reports, batch records, CMC submission documents, etc to assure that such records reflect requisite integrity and comply to applicable requirements
Other duties as assigned
Qualification
Required
Bachelor's degree in health or life sciences, or related field; or relevant experience
Three plus (3+) years of experience in health or life sciences field, or a related area
Excellent written and verbal communication skills, with ability to influence and build credibility at all levels
Strong interpersonal skills for interacting with employees and leaders across various levels and functions
Proven ability to organize and plan work, both independently and in conjunction with team members
Ability to use and maintain spreadsheets in a manner that allows complete and accurate compliance information for presentation purposes
Ability to work with people in a manner that is collaborative and respectful
Ability to take descriptions that are written from a sometimes highly technical perspective and put into plain language
Skilled at developing and reviewing procedural documents
Attention to detail and ability to manage multiple processes and documentation requirements
Strong technical and analytical skills with advanced knowledge in MS Office including Word, Excel, and PowerPoint
Ability to work in a team or independently as required
Outstanding organizational skills with the ability to prioritize
Demonstrated independent and sound decision-making skills; ability to think critically and make decisions in a fast-paced environment
Continuous improvement mindset; seeking ways to drive innovation and efficiencies throughout the organization
Flexible and willing to learn; adapting to business and site needs in a dynamic environment
Maintain a positive, approachable and professional attitude
Benefits
Medical
Dental
Vision insurance
401(k) match
PTO
Paid holidays
Company
Celcuity
Celcuity is a biotechnology company translating discoveries of new cancer sub-types into expanded therapeutic options for cancer patients.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.1BKey Investors
Innovatus Capital PartnersVenrock Healthcare Capital PartnersBrightstone Venture Capital
2025-09-09Post Ipo Debt· $500M
2025-07-30Post Ipo Equity· $85M
2025-07-30Post Ipo Debt· $175M
Leadership Team
Brian Sullivan
Co-Founder, Chairman, CEO
Eldon Mayer
Chief Commercial Officer (CCO)
Recent News
2026-01-09
Company data provided by crunchbase