Senior Compliance Analyst

2 weeks ago


Gwynedd Valley, Pennsylvania, United States TalentBurst Full time
Position Overview:
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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