Location: Louisville, KY
Duration: 18 months assignment with extension up to 3 yrs
IMPORTANT:
- This is a quarterly role with an expectation of 10 hours per quarter. 18 month contract with extension up to 3 yrs
- Shift/Hours: 4-6 hours every quarter for assessment, 4 hours per month for client training. Every 3 months - performing BOP assessments.
- Mostly remote role; onsite once a quarter to do an assessment, possibly training as well.
- Local candidate
- Be a licensed pharmacist in the state of Kentucky
Part time: 4-8 hours per quarter sometimes more due to business demand and audits
Responsibilities
- Be responsible to the client 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 client Louisville KY drug manufacturing facility, per 201 KAR 2:230, Section 5 (link at http://www.lrc.state.ky.us/kar/201/002/320.htm)
- 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 client Louisville KY site head prior to departure.
- Comply with all other applicable laws and regulations in connection with being the PIC at the client Louisville KY 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 client Louisville KY site Operations and Quality head.
- Keep client Louisville KY site head informed of all communications between any regulatory agency (FDA, KBOP, etc.) and the PIC
Top 3 Must Have Skill Sets:
- Licensed pharmacist in the state of Kentucky
- Able to complete BOP on-site survey in a quarterly bases
- Able to complete required training
Possible Extension:
Red Flags:
Interview Process:
- Panel video conference interview with two client leaders on the team
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.