Regulatory Assurance Coordinator
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Job Location:
Centennial, CO - USA
Monthly Salary:
Not Disclosed
Posted on:
20 hours ago
Vacancies:
1 Vacancy
Job Summary
The Regulatory Assurance Coordinator is responsible for ensuring the laboratory stays compliant with all regulatory licensing and accreditation requirements (e.g. CLIA CAP State DOH FDA etc.). This role focuses specifically on regulatory readiness documentation and inspection support. This role involves ensuring adherence to all relevant standards managing documentation facilitating audits and driving continuous quality improvement initiatives within the laboratory setting.
Key Responsibilities:
- Regulatory Compliance & Monitoring:
- Interpret and apply federal state and local regulations and accreditation standards to laboratory operations.
- Regularly review and monitor evolving regulatory requirements and guidelines implementing changes to ensure ongoing compliance.
- Maintain and track all necessary licenses registrations and certifications for the laboratory and its testing activities.
- Conducts readiness reviews and gap analyses in advance of inspections
- Quality Management System (QMS):
- Ensure SOPs and policies are aligned with regulatory standards.
- Participate in SOP review cycles.
- Assist in aligning technical and administrative documents to CAP checklists or FDA expectations.
- Audits & Inspections:
- Coordinate and serve as the primary liaison and host for external client audits regulatory and accreditation inspections (e.g. FDA CAP inspections).
- Conduct regular internal audits and assessments to evaluate compliance and identify potential risks or non-compliance issues.
- Track corrective and preventative actions (CAPA) resulting from audits or incidents ensuring timely and effective resolution and documentation.
- Coordinate post-inspection responses and CAPAs with QA and leadership.
- Data Management & Reporting:
- Maintain dashboards or trackers for:
- Licensing status
- Inspection readiness
- Aduit findings and action plan (corrective/preventive) statuses
- Collect compile and analyze quality data to identify trends issues and improvement opportunities.
- Prepare clear and comprehensive reports on quality metrics audit findings and compliance status for laboratory management and directors.
- Maintain accurate and organized documentation and records in a survey-ready state.
- Maintain dashboards or trackers for:
- Training & Education:
- Assist in the monitoring of staff training and competency assessment programs.
- Provide guidance and support to laboratory personnel on regulatory matters quality standards and safety protocols.
- Problem Solving & Improvement:
- Investigate incidents non-conformances and vendor recall notices communicating findings and resolutions to stakeholders.
- Utilize quality improvement expertise and tools (e.g. root cause analysis) to facilitate best practice development and process improvements.
Qualifications :
- Education: A Bachelors degree in a relevant scientific field (e.g. Medical Technology Clinical Laboratory Science Chemistry Biology) is typically required.
- Experience: 2-5 years of experience in a laboratory setting with specific experience in quality assurance and/or regulatory affairs.
- Knowledge: Extensive knowledge of laboratory regulations (e.g. CLIA CAP FDA) and quality control principles.
- Skills:
- Strong organizational skills and meticulous attention to detail.
- Excellent written and verbal communication skills with the ability to interpret and explain complex regulations.
- Strong analytical and problem-solving abilities.
- Proficiency with laboratory information management systems (LIMS) and Microsoft Office Suite.
- Ability to work both independently and collaboratively in a team environment.
Preferred Qualifications:
- Certification in quality management (e.g. ASQ certification).
- Familiarity with electronic document control systems.
Additional Information :
Compensation:
- $85000 - $105000 per year
Schedule:
- Monday - Friday 8:00am-4:30pm
What we offer:
- Excellent full time benefits including comprehensive medical coverage dental and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
Eurofins USA Clinical Diagnostics is a Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
No
Employment Type :
Full-time
Key Skills
- Quality Assurance
- FDA Regulations
- Data Collection
- Food Industry
- ICH Q7
- ISO 9001
- Hospice Care
- Food Processing
- Quality Management
- cGMP
- QA/QC
- HACCP
About Company
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and the environment safer, healthier and more sustainable. From the food you eat to the medicines you rely on, Eur ... View more
