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Regulatory Compliance Analyst
2 months ago
Position: Compliance Specialist - I & Level III
Company: Integrated Resources, Inc (IRI)
Job Overview:
The Compliance Specialist for Bioanalytical Data and Laboratory Systems is essential in maintaining adherence to established policies, quality benchmarks, operational procedures, and regulatory standards.
Key Responsibilities:
- Conduct thorough quality compliance evaluations of scientific and engineering documentation, ensuring accuracy and completeness.
- Maintain comprehensive records of auditing activities, prepare analytical reports, and oversee the results of audits to foster data integrity and promote ongoing compliance.
- Perform audits on laboratory documentation and departmental processes, ensuring alignment with bioanalytical data standards.
- Prepare necessary documentation for audits conducted by internal staff, including supervisor assessments and project evaluations.
- Identify and recommend enhancements to improve the quality and efficiency of documentation and operational processes.
- Oversee audits related to general departmental functions, including training documentation, policy adherence, and regulatory compliance.
- Execute audits in accordance with a predetermined schedule and established protocols.
- Maintain detailed records of auditing data, including workload specifics and documented findings for analytical purposes.
Qualifications:
- A Bachelor's Degree or higher in a scientific, quality, or engineering discipline.
- Formal training in quality management, including statistical process control, is advantageous.
- A minimum of three to ten years of relevant professional experience.
- In-depth knowledge and practical experience with quality management systems and regulations, such as Good Laboratory Practices (GLP) or Good Manufacturing Practices (GMP).
- Proficient in conducting laboratory inspections, audits, and investigations, as well as performing root cause analyses and implementing corrective actions.
- Experience with testing protocols, quality metrics, and statistical evaluations.
- Familiarity with document control, change management, and risk assessment processes.
- Proven ability to collaborate with cross-functional teams to ensure compliance and drive continuous improvement.