Pharmacist in Charge, Biotech GMP Light Part-Time (JP10447)
3 Key Consulting
Pharmacist in Charge, Biotech GMP Light Part-Time
Location: Louisville, KY, 40201
Employment Type: Contract
Duration: 9 months with likely extensions
Shift/Hours: 2--4 hours every quarter for assessment, 4 hours per month for trainings. Every 3 months - performing BOP assessments.
Job Description
Be responsible to the company Louisville KY site head and Manufacturing area Management for the performance of their duties.
Be responsible to the Kentucky Board of Pharmacy (KBOP) for the security and record keeping of the Louisville KY drug manufacturing facility, per 201 KAR 2:230, Section 5.
Conduct an on-site inspection of security and record keeping not less than quarterly.
Prepare in advance, as needed, to conduct on-site inspections.
At the conclusion of each on-site inspection, prepare and deliver a written and signed report of the on-site inspection to the site head prior to departure.
Comply with all other applicable laws and regulations in connection with being the PIC at the manufacturing site.
Comply with all regulatory or governmental agency reporting requirements two weeks in advance of deadlines.
Be available to answer questions or respond to comments from any applicable regulatory agency (FDA, KBOP, etc.) in a timely manner.
Respond to questions or comments from any applicable regulatory agency (FDA, KBOP, etc.) in a timely manner, after consulting with the site head.
Keep site head informed of all communications between any regulatory agency (FDA, KBOP, etc.) and the PIC.
Why is the Position Open?
Backfill- handover
Top Must-Have Skill Sets
- Licensed pharmacist in the state of Kentucky
- Proficient in the BOP requirements per 201 KAR 2:230, Section 5 (link at
- Great interpersonal skills; communication, etc
- Familiar GMP environment
- Computer efficient
Red Flags
No valid Pharmacist license in KY
Interview Process
Video Conference
We invite qualified candidates to send your resume to View email address on click.appcast.io. If you decide that you're not interested in pursuing this position, please feel free to look at the other positions on our website You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.
3 Key ConsultingVacancy posted 3 days ago
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