Quality Assurance Coordinator

Title: Quality Assurance Coordinator

Location: Remote

Position Summary:

Celcuity’s Quality Assurance (QA) Group is responsible for the following four functions:

1. Control of policies and process standards, as well as the administration of the company’s Content Management System for research records
2. Audit Management and Reporting
3. Incident and Observation Processing
4. Continuous Inspection Preparedness

We are seeking a Quality Assurance Coordinator who will report into the Vice President, Quality Assurance. You will  work within the Quality Assurance Group and have the primary responsibility for registering, tracking, documenting, communicating, and summarizing quality- related data for Celcuity’s pharmaceutical division. Quality-related data include the following main categories:

• Noncompliant events (Quality Incidents) related to GxP projects
• Employee qualification and training documentation
• Reviews/audits of clinical research documents (i.e., protocols, plans, Investigator’s Brochures, Clinical Study Reports)
• GxP vendor evaluation, selection, and oversight
• Results of checks on individuals and companies for debarment, enforcement actions, and sanctioned activities
• Metrics on these and other QA activities

These data are essential to the Quality Assurance Group’s management of functions identified above as items 1, 2, 3, and 4.

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.

Qualifications:

• 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.

About Us:

Celcuity is a clinical-stage, publicly traded biotechnology company seeking to extend the lives of cancer patients through the development of targeted therapies for the treatment of multiple solid tumor indications. The company was founded to develop a better way to treat the cellular drivers of tumor growth.

Our lead therapeutic candidate, gedatolisib, is an intravenously administered, potential first-in-class PI3K/AKT/mTOR (PAM) pathway inhibitor. Its mechanism of action and pharmacokinetic properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together. Gedatolisib phase 3 clinical development programs are focused on the treatment of patients with HR+/HER2- ABC in the 1L and 2L settings. A Phase 1b/2 clinical trial evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is on-going.

Celcuity is an Equal-Opportunity Employer.

Celcuity is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are competitive. For this role, the anticipated base pay range is $ - $. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience.

The successful candidate will be eligible for an annual performance incentive bonus and a new hire equity package. Celcuity also offers various benefits offerings, including, but not limited to, medical, dental, vision insurance, 401(k) match, PTO, and paid holidays.

Notice to Recruiters/Staffing Agencies 

Recruiters and staffing agencies should not contact Celcuity through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees directly.

We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file.

Celcuity’s receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Celcuity and such organization and will be considered unsolicited. Celcuity will not be responsible for related fees.