Compliance and Regulatory Affairs Analyst

1 week ago

Arvada, Colorado, United States AA2IT Full time
Job Overview

Position: Compliance and Regulatory Affairs Analyst

Compensation: Level: 1 - Rate: $32 - Minimum Experience: 3 years
Level III: Rate: $52 - Minimum Experience: 10 years

Educational Requirements:
- A Bachelor's degree in a relevant field such as Quality Assurance, Engineering, Chemistry, Biology, Compliance, or a related discipline.
- Formal Quality Training, including statistical process control or a quality-related qualification, is advantageous.

Qualifications and Experience:
- At least 5 years of professional experience in compliance, regulatory affairs, or a related area.
- Comprehensive knowledge of pertinent regulations and compliance concepts relevant to the biotherapeutic sector, including FDA regulations such as 21CFRs.
- Proven track record in managing compliance programs, policies, and procedures.

Key Skills and Competencies:
- Exceptional attention to detail when reviewing technical documentation to ensure compliance with established standards.
- Demonstrated experience in conducting compliance audits, investigations, and risk assessments.
- Familiarity with developing and implementing compliance training programs for personnel.
- Strong ability to build and maintain relationships with regulatory authorities as applicable.
- In-depth knowledge of compliance frameworks, best practices, and industry standards.
- Excellent understanding of risk management methodologies to identify and mitigate compliance risks.
- Strong analytical and problem-solving skills to navigate complex regulatory requirements and devise compliant solutions.
- Outstanding communication and interpersonal skills to convey compliance requirements and policies effectively to various organizational levels.
- Ability to collaborate and work effectively with cross-functional teams and influence stakeholders.

Primary Responsibilities:

The Compliance and Regulatory Affairs Analyst will play a pivotal role in ensuring adherence to policies, quality standards, workflow procedures, and regulatory requirements. Responsibilities include:

  • Conducting compliance audits of records and lab systems, maintaining detailed auditing records, and preparing reports to support data integrity and continuous compliance.
  • Participating in performance improvement projects related to key departmental processes.
  • Serving as the compliance expert for the department, supporting regulatory and accreditation survey activities.

Major Responsibilities:

Compliance Audits:
- Conduct thorough audits of records to ensure completeness and accuracy.
- Audit processes related to bioanalytical data and lab systems.
- Identify opportunities for enhancing the quality and efficiency of records and processes.

Compliance Analytics:
- Utilize tools and methods to organize and analyze auditing data.
- Generate metrics and analytics to monitor compliance and identify trends.

Department Support:
- Act as the department's compliance expert, providing training on documentation best practices.
- Collaborate on quality initiatives and participate in departmental committees.

Company Overview:
AA2IT is dedicated to your success through effective strategy execution and value creation. We focus on aligning business and technology strategies to drive tangible results. As a global firm headquartered in Texas, we specialize in Staffing and IT Solutions, leveraging a fully digital approach with a people-centric and technology-driven vision.

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