What are the responsibilities and job description for the Quality Control - Pharmacy position at Dr. Vince Clinical Research?
POSITION SUMMARY: The Quality Control staff member is responsible for ensuring the quality and release of correct study drug preparation in compliance with cGMP and local and federal regulations.
KEY RESPONSIBILITIES:
· Communicate with Director of Pharmacy Operations regarding any investigational or non-investigational drug matters or concerns.
· Assist in the preparation and verification of study drug for dispensation in accordance with an IRB-approved protocol, pharmacy manual, or other sponsor provided document.
· Ensure each batch is prepared correctly and is in compliance with cGMP regulations.
· Has the authority to stop preparation in the event of concern for the quality of the product being prepared.
· Oversee the quality control of general pharmacy operations.
· Provide input so processes are up-to-date and assist in process improvement.
· Review and provide input on SOP, Work Instructions, and guidance documentation.
· Support Director of Pharmacy to ensure pharmacy functions within GMP/ICH/GCP/USP regulations.
· Work closely with the Director of Pharmacy in the management of equipment.
· Assist in keeping the pharmacy clean.
· Assist in managing supply inventory.
· May represent the pharmacy during client/sponsor meetings, teleconferences, videoconferences.
· Assist Director of Pharmacy with communication between departments, study managers, and third-party vendors to accommodate pharmacy related study needs.
· Review of protocols, pharmacy manuals, or other study documents.
REQUIRED QUALIFICATIONS:
- At least 1 year in a clinical research environment
PREFERRED QUALIFICATIONS:
· Sterile compounding experience
Job Type: Full-time
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Parental leave
- Referral program
- Vision insurance
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
- Weekends as needed
Work Location: In person
