Inspection Readiness Specialist
Supports activities to ensure Bioclinica’s Medical Imaging services maintain an inspection ready status and ensuring that departments and projects are prepared for regulatory inspections through executing the following responsibilities:
- Training and preparing personnel for regulatory inspections
- Auditing and/or reviewing processes and projects with a focus on inspection readiness
- Coordinating mock inspections
- Preparing “storyboards” and other materials in preparation for anticipated inspections
- Assembling key personnel for inspection support
- Managing / coordinating logistics for inspections
- Assisting follow-up of inspection findings, quality event reports, and CAPAs to support their timely resolution and closure.
- Tracks and trends inspection related issues and drives process improvements for those issues
- Tracks, researches external inspection and regulatory trends and communicates those internally to applicable Bioclinica personnel.
- Supports SOP development, review, and revision
Maintain quality service and departmental standards by:
- Reading, understanding, and adhering to organizational standard operating procedures (SOPs)
- Assisting in establishing and enforcing departmental standards
Contribute to team effort by:
- Working with internal staff to resolve issues
- Exploring new opportunities to add value to organization and departmental processes
- Helping others to achieve results
- Performing other duties as assigned
Maintain technical and industry knowledge by:
- Attending and participating in applicable company-sponsored training
- Attending educational workshops and reviewing professional publications
- Keeping informed of changes in the regulatory environment and/or regulatory requirements
- Bachelor’s degree or equivalent regulatory and inspection readiness experience / certification.
- 2+ years in inspection readiness, regulatory affairs/compliance or quality assurance
- 2+ years’ experience in conducting or leading inspection readiness activities (e.g. preparing for, managing, hosting inspections) within a CRO or pharmaceutical firm
- Excellent knowledge of GCP, ICH guidelines, FDA regulations as well as regulatory agency inspection practices
- Experience working with computer software including Word, Excel, MS Access and QMS software
- Strong interpersonal and communication skills, both verbal and written
- Unwavering commitment quality and compliance
- Strong documentation and organizational skills
- Goal oriented Ability to make sound judgments
- Superior problem-solving skills
- Ability to manage multiple tasks effectively & efficiently
Lifting: 0-25 lbs.
Other: Computer work for long periods of time
Bioclinica is an equal opportunity employer. Bioclinica evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
This JOB description should not be deemed all-inclusive. Additional requirements and expectations may be assigned. At all times, employees are expected to adhere to company policies and company SOPs.