At Altasciences, the business problem is to ensure regulatory compliance in the discovery, development, and manufacturing of new drug therapies by conducting systematic and independent examinations of study-related activities and documents.
Requirements
- 2-3 years of related technical experience and/or training.
- 2+ years experience auditing in a GLP-regulated environment.
- Professional certification such as RQAP-GLP (Registered Quality Assurance Professional-GLP) or ASQ-CQA (American Society of Quality– Certified Quality Auditor) or other certification is recommended.
- Training needs for this position include on-the-job training in performing audits and inspections, and independent reading of professional articles, journals and internal SOPs.
- Attendance at training seminars, regional and national meetings in Quality Assurance, regulatory affairs and validation, along with continual GLP training.
- Knowledge of FDA regulations and GLP (21 CFR Part 58 and Part 11).
- Experience with quality assurance and regulatory compliance in a laboratory or pharmaceutical setting.
Responsibilities
- Audits phases of nonclinical and laboratory studies, reports, and performs related duties (e.g., issues audits and QA statements) to ensure regulatory compliance.
- Audits all disciplines (examples of disciplines include Method Validations, Non- Clinical GLP Studies).
- Performs in-life audits, process audits, vendor qualifications, equipment and software validation audits.
- Performs facility audits to ensure that the facility is in compliance with regulations.
- Acts as lead auditor on studies and projects.
- Maintains computerized files to support audit activities.
- Supports project planning and implementation.
Other
- Bachelor degree or higher in a scientific discipline, or equivalent combination of education and experience.
- Ability to work in a team environment and build effective working relationships throughout the organization.
- Ability to mentor/coach lower-level staff.
- Excellent communication and interpersonal skills.
- Ability to work autonomously and make decisions with minimal supervision.
