Senior Compliance Analyst
2 weeks ago
The Compliance Specialist for Bioanalytical Data and Lab Systems is essential in maintaining adherence to organizational policies, quality benchmarks, workflow methodologies, and regulatory standards.
Key Responsibilities:
- Compliance Audits:
Conduct thorough evaluations of scientist and engineer documentation to verify completeness and accuracy. Review lab systems and processes to ensure compliance with established protocols. - Audit Preparation:
Organize and prepare records for internal and external audits, ensuring all documentation is readily available and accurate. - Data Integrity Monitoring:
Continuously assess auditing results and maintain detailed records of findings, recommendations, and corrective actions. - Performance Improvement:
Contribute to initiatives aimed at enhancing departmental processes and serve as the compliance authority during regulatory assessments.
Analytics and Reporting:
- Utilize analytical tools to compile and interpret auditing data, generating reports that highlight compliance metrics and trends.
- Present findings to internal stakeholders and recommend strategies for achieving compliance objectives.
Departmental Support:
- Act as the compliance resource for the department, providing training and guidance on documentation practices and compliance standards.
- Engage in quality improvement projects and collaborate with teams to enhance compliance processes.
Qualifications:
- A Bachelor's degree in a relevant discipline such as Quality Assurance, Engineering, or Compliance.
- A minimum of 10 years of experience in compliance or regulatory affairs.
- In-depth knowledge of industry regulations and compliance frameworks.
Skills:
- Exceptional attention to detail and analytical skills.
- Strong communication and interpersonal abilities.
- Proficiency in compliance software and Microsoft Office Suite.
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