What are the responsibilities and job description for the GMP Auditor position at Actalent?
Description:
- Monitoring each study to assure management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with the regulations.
- Assessing Vendors for Compliance and monitoring studies performed at the vendors
- Providing audit reports for audits / assessments performed.
- Assisting as necessary with the internal activities to conform with the regulations
- Maintaining copies of all protocols pertaining to all nonclinical laboratory studies for which the unit is responsible.
- Periodically submit to management and the study director written status reports on each study, noting any problems and the corrective actions taken.
- Determine that no deviations from approved protocols or standard operating procedures were made without proper authorization and documentation.
- Review the final study report to assure that such report accurately describes the methods and standard operating procedures, and that the reported results accurately reflect the raw data of the nonclinical laboratory study.
- Prepare and sign a statement to be included with the final study report which shall specify the dates inspections were made and findings reported to management and to the study director.
- Daily support of the data integrity and quality assurance program for Preclinical.
- Ensuring that appropriate quality auditing programs & related documentation is established & maintained in the area.
- Numerous administrative responsibilities & requires the ability to coordinate personnel for audit activities, educate & train associates in practices.
Additional Skills & Qualifications:
- Individuals should have hands-on GxP Auditing experience.
- Familiar with Laboratory Animal Care & Use Practices, such as Animal Welfare Act.
- Experience with Auditing (CROs, Study Audits, System Audits).
- Society of Quality Assurance Membership / participation / certification is preferred.
- BS or equivalent degree
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
Salary : $37 - $42
