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Regulatory Affairs Specialist

3 months ago

West Point, United States AA2IT Full time
Job DescriptionJob Description

Level: 1 - Rate: $32 - Min Exp : 3 plus

Level III: Rate : $52 min Exp : 10 years 

Education:
- 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 quality related qualification a plus.
Qualification/Experience
- A minimum of 5 years + of professional experience in compliance, regulatory affairs, or a related field.
- Extensive knowledge and understanding of relevant regulations and compliance concepts relevant to the biotherapeutic industry, such as FDA regulations, such as 21CFRs.
- Proven experience in managing compliance programs, policies, and procedures.
Skills and Competencies
- Attention to detail when reviewing technical and other documentation for accuracy and completeness to ensure adherence to established standards and protocols; ability to ‘read for meaning’ and identify basic non-compliance issues.
- Demonstrated experience in conducting compliance audits, investigations, and risk assessments.
- Familiarity with developing and implementing compliance training programs for employees.
- Strong experience in developing and maintaining relationships with regulatory authorities, if applicable to the industry.
- Strong knowledge of compliance frameworks, best practices, and industry standards.
- Excellent understanding of risk management methodologies and the ability to identify and mitigate compliance risks.
- Strong analytical and problem-solving skills to assess complex regulatory requirements and develop compliant solutions.
- Excellent communication and interpersonal skills to effectively communicate compliance requirements, policies, and training to employees at various levels within the organization.
- Ability to communicate, collaborate, and work effectively with cross-functional teams and influence stakeholders to ensure compliance.
- Proficiency in using compliance software tools and systems.
- Computer skills: High level of proficiency - Excel, Word, Power Point, Outlook, LIMS
- Possess a sound and logical approach to problem solving.
- Must have good collaboration skills with team and stakeholders.

Responsibilities:

The Compliance Specialist for Bioanalytical Data and Lab Systems will play a critical role in ensuring compliance with policies, quality standards, workflow procedures, and regulatory and accreditation requirements. This position will be responsible for conducting compliance audits of scientist/engineer records and lab systems, maintaining detailed auditing records, preparing trending reports, and monitoring auditing results to support optimal data integrity and continuous innovation and compliance. Additionally, the Compliance Specialist will contribute to performance improvement projects related to key department processes and serve as the department's compliance expert, supporting regulatory and accreditation survey activities.

MAJOR RESPONSIBILITIES
Compliance Audits
- Conduct audits of scientist/engineer records to ensure completeness, accuracy, and appropriateness, including comparing source data to the records for accuracy and analyzing select data in detail.
- Audit department records and processes related to the bioanalytical data and lab systems, such as feedback surveys, after action reviews, and lab documentation.
- Prepare records for audits performed by other staff, such as supervisor reviews, project reviews, and internal audits.
- Identify opportunities for improving the quality and efficiency of records and processes.
- Participate in the preparation, facilitation, and follow-up activities for regulatory and accreditation surveys.
- Audit department records and processes related to general department functions, including training records, timekeeping, policy management, lab development plans/assessments/activities, and regulatory records.
- Complete audits according to an established schedule and procedures.
- Maintain detailed auditing data, including workload details and documented findings, recommendations, and corrections, for analytics.
- Inform and educate staff about audit findings, recommendations, and corrections.
- Report audit findings, recommendations, and corrections to internal leadership and complete follow-up activities as directed.
- Monitor and follow up on requested audit corrections to ensure completion.
- Develop audit and documentation/recordkeeping policies, procedures, and workflows.

Compliance Analytics
- Utilize tools, systems, and methods to organize and catalog various auditing data.
- Perform data and statistical analysis on auditing data to generate metrics and other tracking and trending analytics.
- Interpret and monitor metrics and analytics to identify trends and compliance towards auditing goals, expectations, and benchmarks.
- Establish auditing goals, expectations, and benchmarks and ensure they are met or exceeded.
- Prepare and present analytics to internal leadership and external audiences.

Department Support
- Serve as the department's Compliance Expert, providing coaching, mentoring, and training on proper documentation/recordkeeping best practices and auditing practices.
- Recommend, lead, and participate in performance improvement projects.
- Collaborate on quality initiatives within and across the regulated bioanalytics organization.
- Deliver training on compliance processes to new and current employees.
- Participate in department committees, teams, and workgroups.
- Serve as a backup for quality and regulatory staff duties.
- Complete ongoing training and professional development.
- Contribute to the maintenance of the Business Continuity Plan.
- Participate and Lead remediation efforts within the department.

 

Company DescriptionAA2IT is in this business to make you successful. Strategy, Execution and Value. There are too many businesses that have solid, well-thought-out strategies that sit in a drawer somewhere collecting dust. Executing on Strategy effectively and measuring what matters drives the value. We start with your business strategy, align technology strategy, and create a roadmap that gets your business value.

AA2IT is a global firm providing Staffing and IT Solutions. We are headquartered in Texas, delivering successful talent acquisition and technology services. We are fully digital organization with a people centric and a technology driven vision.Company DescriptionAA2IT is in this business to make you successful. Strategy, Execution and Value. There are too many businesses that have solid, well-thought-out strategies that sit in a drawer somewhere collecting dust. Executing on Strategy effectively and measuring what matters drives the value. We start with your business strategy, align technology strategy, and create a roadmap that gets your business value.\r
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AA2IT is a global firm providing Staffing and IT Solutions. We are headquartered in Texas, delivering successful talent acquisition and technology services. We are fully digital organization with a people centric and a technology driven vision.