Pharmacist in Charge- PART TIME (JP4826)

Location: Louisville, KY
Date Posted: 10-05-2018
Job Title:  Pharmacist in Charge-PART TIME (JP4826)
Location: Louisville, KY. 40201
Employment Type:  Contract- PART TIME
Business Unit:  GSC NACO Distribution
Duration:  3 years
 
3Key Consulting Inc. is recruiting for a Pharmacist in Charge-PART TIME with current Kentucky pharmacy licensure and knowledge of the 201 KAR 2:230, section 5; GMP experience and knowledge of GMP manufacturing and distribution processes for a global, CA-based, bio-pharmaceutical company. 
 
Job Description:
  • Be responsible to the Amgen 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 Amgen 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 Amgen Louisville KY site head prior to departure.
  • Comply with all other applicable laws and regulations in connection with being the PIC at the Amgen 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 Amgen Louisville KY site head.
  • Keep Amgen Louisville KY site head informed of all communications between any regulatory agency (FDA, KBOP, etc.) and the PIC.
 
Top Must-Have Skill Sets:
  • Current Kentucky Pharmacy license and knowledge on the 201 KAR 2:230, Section 5.
  • GMP experience.
  • Knowledge in GMP manufacturing and distribution processes.
 
Day to Day Responsibilities
  • Be responsible to the Amgen Louisville KY site head for the performance of their duties.
  • Be responsible to the Kentucky Board of Pharmacy (KBOP) for the security and record keeping of the Amgen 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.
    • Standards against which the facility is to be inspected (201 KAR 2:230, Section 4, (link at http://www.lrc.state.ky.us/kar/201/002/320.htm): (l) Facilities.
    • All buildings in which legend drugs are repackaged, stored, held, sold, offered for sale, exposed for sale, or kept for sale shall be of suitable size, construction, and location to facilitate cleaning, maintenance, and proper operations.
    • Buildings shall meet all applicable federal, state, and local standards. The facility shall have a quarantine area for storage of prescription drugs that are outdated, damaged, deteriorated, misbranded, or adulterated, or that are in immediate or sealed secondary containers that have been opened.
    • A facility shall not be located in a residence.
  • Security.
    • A manufacturer shall be equipped with an alarm system to detect entry after hours.
    • A manufacturer shall ensure that access from outside their premises is well controlled and reduced to a minimum. This includes the installation of adequate lighting at the outside perimeter of the premises.
    • Internal security policies shall be developed to provide reasonable protection against theft and diversion by limiting access to areas where legend drugs are held to authorized personnel. These policies shall provide protection against tampering with computers or electronic records.
    • A permit holder shall employ adequate personnel with the education and experience necessary to safely and lawfully engage in the manufacturer of prescription drugs.
    • Lists of officers, directors, managers and other persons in charge of distribution, storage, and handling of prescription drugs, including a description of their duties and summary of their qualifications, shall be maintained for purpose of review.
  • Record keeping.
    • Inventories and other records of transactions regarding the receipt and disposition of legend drugs shall be maintained and readily available for inspection or photocopying by authorized law enforcement officials for a period of two years following disposition of the drugs. These records shall include:
      • The source of the drugs including the name and principal address of the seller or transferor and the address of the location from which the drugs were shipped;
      • The identity and quantity of the drugs received and distributed or disposed of; and
      • The dates of receipt and distribution or other distribution of the drugs.
    • Records described in this section that are kept at the inspection site or that can be immediately retrieved by computer or other electronic means shall be readily available for authorized inspection during the retention period.
    • Records kept at a central location apart from the inspection site and not electronically retrievable shall be made available for inspection within two (2) working days of a request by an authorized official of a federal, state, or local law enforcement agency.
  • Written policies and procedures.
    • A manufacturer shall establish, maintain, and adhere to written policies and procedures for the receipt, security, storage, inventory, and distribution of prescription drugs, including policies and procedures for identifying, recording, and reporting losses or thefts and to ensure that the manufacturer prepares for, protects against, and handles crisis situations that affect the security or operation of the facility. These crises shall include fires, floods, or other natural disasters, and situations of local, state, or national emergency.
    • There shall be written policies and pro.
 
Why This Position Is Open:
Backfill of a current EW leaving.
 
Employee Value Proposition:
Gain Amgen experience.
 
Red Flags:
  • Not enough experience in related field.
  • No current KY state license.
 
Interview process:
Phone followed by in-person interview.
 
We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com. You are also welcome to share this posting with anyone you think might be interested in applying for this role.
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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