QA Manager, Audits and Inspections
FUJIFILM Corporation
Clinical Research Pharmacist
Celerion
full-time
Posted on:
Location Type: Office
Location: Lincoln • New York • 🇺🇸 United States
Visit company websiteJob Level
Junior
About the role
- Responsible for receipt, storage, preparation, disposition, and retention of all study investigational products in compliance with standard operating procedures, FDA, and DEA regulations concerning investigational product handling, accountability and security. Review and understand study protocol requirements in regard to investigational product handling.
- Active member of study team providing expertise and support such as evaluating study feasibility, study set up and conduct, participating in internal and/or external client meetings. Provide internal and/or external client communication and interaction regarding investigational product handling and protocol specific requirements.
- Knowledge of relevant United States Pharmacopeia guidelines, including chapters 795, 797, 800, 1163, and 1168 as well as the FDA Guidance for Industry CGMP for Phase 1 Investigational Drugs required.
- Maintain aseptic compounding evaluation requirements.
- Provide training and monitoring for administration of investigational products as needed.
- Review and provide input to standard operating procedures and training plans pertaining to pharmacy and assisting with pharmacy training as necessary.
- Maintain pharmacy department equipment and applicable records as necessary.
- Institutional Review Board consultant and resource.
- Assist in training of new hires and students.
- Additional Essential Functions if assigned the “Designated Person” role: Work with the Pharmacist in Charge to ensure compliance with current USP guidelines and applicable Celerion SOP’s pertaining to extemporaneous pharmacy compounding; Review applicable compounding SOP’s every 12 months to ensure continued compliance with USP guidelines and implement changes, as appropriate; Ensure the CAPA system is initiated when warranted; Oversee pharmacy personnel compounding training program; Oversee compliance with USP guidelines; Oversee monitoring of the Designated Compounding Areas; Review and maintain all pharmacy compounding certification records (personnel and facility) to ensure completeness and compliance; Recognize problems, deviations, failures, and errors in the compounding process and the facility and report all issues to the Pharmacist in Charge.
Requirements
- Registered Pharmacist required
- Doctor of Pharmacy preferred but not required
- Proven pharmaceutical experience of minimum 1-2 years
- Proven record keeping skills with extreme attention to detail
- Knowledge of United States Pharmacopeia guidelines, including chapters 795, 797, 800, 1163, and 1168 as well as the FDA Guidance for Industry CGMP for Phase 1 Investigational Drugs required
- Completion of media bi-annual media fill and fingertip testing (as applicable per site)
- Knowledge of FDA and EU regulations preferred (if appropriate)
- Job-specific training is required and will be provided
- Full time positions - requires flexible work hours for early morning and occasional on-call weekend availability
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
aseptic compoundingrecord keepingmedia fill testingfingertip testinginvestigational product handlingstudy protocol evaluationpharmacy trainingcompliance monitoringcompounding SOP reviewCAPA system management
Soft skills
attention to detailclient communicationteam collaborationtraining and mentoringproblem recognitionorganizational skillsinterpersonal skillsleadershipadaptabilityflexibility
Certifications
Registered PharmacistDoctor of Pharmacy (preferred)
