Senior Compliance Analyst

2 weeks ago


Gwynedd Valley, Pennsylvania, United States eTeam Full time

Position: Senior Compliance Analyst

Company: eTeam

Role Overview:

The Senior Compliance Analyst will be pivotal in upholding adherence to organizational policies, quality benchmarks, procedural workflows, and regulatory standards. This role encompasses the execution of compliance evaluations of scientific and engineering documentation, alongside laboratory systems, while maintaining comprehensive records of audits, generating analytical reports, and overseeing audit outcomes to ensure data integrity and foster continuous compliance and innovation.

Key Responsibilities:

Compliance Evaluations

- Conduct thorough evaluations of scientific and engineering documentation to verify completeness and accuracy, including detailed comparisons of source data.

- Review departmental records and processes associated with laboratory systems, including feedback mechanisms and documentation.

- Prepare documentation for audits conducted by internal personnel.

- Identify enhancement opportunities for record quality and operational efficiency.

- Engage in preparation and follow-up for regulatory assessments.

- Audit records related to general departmental functions, including training documentation and policy management.

- Maintain detailed records of auditing activities, including findings and recommendations.

- Communicate audit results and necessary corrections to relevant stakeholders.

- Develop policies and procedures for auditing and documentation practices.

Compliance Analytics

- Utilize various tools and methodologies to organize and analyze auditing data.

- Conduct statistical analyses to generate compliance metrics and tracking analytics.

- Monitor and interpret metrics to identify trends and ensure compliance with established goals.

- Prepare and present analytical findings to internal and external stakeholders.

Qualifications:

- Bachelor's degree in a relevant field such as Quality Assurance, Engineering, or Biology.

- A minimum of 10 years of experience in compliance or regulatory affairs.

- Extensive knowledge of regulations pertinent to the biotherapeutic sector.

Skills and Competencies:

- Strong attention to detail in reviewing documentation for compliance.

- Proven experience in conducting compliance audits and risk assessments.

- Excellent communication skills for conveying compliance requirements effectively.

- Proficiency in compliance software and tools.

Departmental Support:

- Act as the compliance expert within the department, providing guidance and training on best practices.

- Participate in quality improvement initiatives and departmental committees.

- Engage in ongoing professional development and training.



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