Quality Assurance Coordinator
Celcuity
full-time
Posted on:
Location Type: Remote
Location: United States
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About the role
- 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.
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.
Benefits
- medical, dental, vision insurance
- 401(k) match
- PTO
- paid holidays
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
quality assuranceGxP compliancedata integrityanalytical protocolsbatch recordsprocedural document developmentrisk assessmentFDA regulationscompliance documentationmetrics development
Soft skills
written communicationverbal communicationinterpersonal skillsorganizational skillscollaborationattention to detaildecision-makingcritical thinkingflexibilitycontinuous improvement mindset