Samples Coordinator

SUMMARY:

Responsibilities also include samples verification, set up and communication for transfer.

Responsibilities also include Batch Record receiving. Ensure the correct data is entered in the Dashboard such as the date BR was received, COE, and NCR number/Investigation number (if applicable).

The impact of samples process directly impacts company compliance to regulatory requirements and customer satisfaction.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

The following is a list of minimum responsibilities related to the Batch Record Review Samples Coordinator position. Other duties may also be assigned.

• Responsible for logging and maintaining packaging process samples as well as coordinating shipment of samples to customers.
• Responsible for gathering required paperwork for verification of samples and to send to SD (Specialty Distribution)/Sample Program Team.
• Responsible for verifying samples dropped off at the Sample Center/BRR office, as well as samples in the warehouse, cold room, controlled drug cage or vault.
• Responsible for preparing pallet(s), cold room box, bins, etc., with samples to be transferred.
• Responsible for sending out communication for samples transfer.
• Responsible for pulling extra samples from serialized and/or non-serialized lots when needed. This includes but not limited to; Responsible for backfilling shippers/cases, if less than the amount of a full shipper is pulled.
• Responsible for printing out or requesting a printout of an updated SPT report, and attaching it to the BR, when serialized samples are pulled.
• Responsible for requesting and ensuring finished goods quantities in inventory are updated after additional samples are pulled.
• Responsible for entering samples data in QAD.
• Responsible for maintaining Line Reference Samples by entering samples specific information into the Quality Dashboard (Smartsheet).
• Review Batch Record documentation on an as-needed basis to ensure accuracy, completeness, and regulatory compliance.
• Other responsibilities as required.
  
  

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

SUPERVISORY RESPONSIBILITIES:

None

PREFERRED / REQUIRED EDUCATION and/or EXPERIENCE:

High School Degree is required. One to two years related pharmaceutical experience and/or training; or equivalent combination of education and experience is preferred. Experience in pharmaceutical or related industry is desired.

• General knowledge of FDA regulations related to cGMPs required.
• General knowledge of cGDPs required.
• General knowledge of quality control/assurance required.
• General knowledge of DEA regulations preferred.
• Excellent attention to detail skills as they apply to documentation review and compliance required.
• Good written and oral communication skills required.
• Good organizational and planning skills required.
• Excellent interpersonal skills required.
  
  

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to use hands, speak and listen. The employee frequently is required to stand, walk, and reach with hands and arms. The employee is occasionally required to sit. The employee is occasionally required to enter a cold room. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus.

WORK ENVIRONMENT:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

DISCLAIMER:

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.