Pharmacist In Charge

Spectraforce Technologies, Inc.; Louisville (KY); Hybrid; USD 83,000 - 96,000; Part time

Job summary

Spectraforce Technologies, Inc. seeks a Pharmacist In Charge (Part-Time) for Louisville, KY. This 18-month assignment is largely remote, with quarterly on-site assessments and training.

Local Kentucky licensure is required; the role reports to the Louisville site head and Manufacturing management. Expect periodic onsite reviews and regulatory coordination with KBOP and FDA. The position requires completing quarterly BOP surveys, adhering to all regulatory obligations, and maintaining strict

Qualifications

• Licensed pharmacist in the state of Kentucky.
• Able to complete BOP on-site survey in a quarterly basis.
• Able to complete required training.

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.
• 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

Skills

Licensed pharmacist KY

BOP on-site survey

Required training

Job description

Job Title: Pharmacist In Charge (Part-Time)

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:

• Yes

Red Flags:

• NA

Interview Process:

• Panel video conference interview with two client leaders on the team