Quality Assurance Coordinator

Celcuity

3d•Remote

About The Position

Celcuity’s Quality Assurance (QA) Group is responsible for the following four functions: Control of policies and process standards, as well as the administration of the company’s Content Management System for research records Audit Management and Reporting Incident and Observation Processing 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.

Requirements

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.

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.