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Senior Compliance Analyst

2 months ago

Gwynedd Valley, Pennsylvania, United States TalentBurst Full time
Position Overview:
The Compliance Specialist for Bioanalytical Data and Laboratory Systems will be pivotal in upholding adherence to established policies, quality benchmarks, operational protocols, and regulatory standards.

Key Responsibilities:
  • Compliance Audits:
    Conduct thorough evaluations of scientist and engineer documentation to ensure accuracy and completeness. This includes a detailed comparison of source data with records and an in-depth analysis of selected data.
  • Audit Preparation:
    Organize records for audits conducted by other personnel, including supervisor assessments and internal reviews. Identify areas for enhancement in record quality and efficiency.
  • Regulatory Support:
    Assist in the preparation and execution of regulatory surveys, ensuring compliance with departmental functions, including training documentation and policy management.
  • Data Analytics:
    Utilize various tools and methodologies to catalog auditing data, performing statistical analyses to generate metrics and track compliance trends.
  • Departmental Expertise:
    Act as the department's compliance authority, providing guidance and training on documentation best practices and participating in quality improvement initiatives.

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, with a comprehensive understanding of relevant regulations.
  • Strong analytical skills and the ability to communicate compliance requirements effectively across various organizational levels.

Skills:
  • Attention to detail and proficiency in compliance software tools.
  • Ability to develop and maintain relationships with regulatory bodies.
  • Excellent problem-solving skills and a collaborative approach to working with cross-functional teams.