Panther Premium Logistics

LFS Quality Assurance Coordinator

Job ID
2017-1383
# of Openings
1
US-OH-Medina

Overview

General Summary:

The primary responsibility of the Life Sciences (LFS) Quality Assurance Coordinator is to monitor the adherence of the fleet and the operations staff for compliance to the Temperature Validated Program (TVP) requirements. Primary methods of monitoring include the collection and inspection of historical data as well as live, real-time, monitoring of shipments that fall into the TVP program. Additionally, the LFS Quality Assurance Coordinator must be able to fulfill certain duties of the Life Sciences Quality Manager when the Quality Manager is unavailable or otherwise unable to fulfill those duties that are required for the uninterrupted continuance of Life Sciences business.

 

Responsibilities

Essential Duties & Responsibilities:

  • Track, assign, initiate, and coordinate deviations and corrective actions as needed for the department.
  • Perform contractor training related to LFS (Life Sciences) /TVP (Temperature Validated Program) requirements and protocols and administer necessary testing and review prior to contractors entering the LFS program.
  • Perform new employee training related to LFS/TVP requirements as well as recurrent training to established staff as needed or dictated by the LFS Operations Manager or LFS Quality Manager.
  • Monitor shipments and shipment alerts for TVP quality purposes.
  • Perform internal audits of departmental customer service duties for quarterly reports.
  • Identify areas to improve quality service (preventative actions) to Life Sciences customers.
  • Assist Life Sciences Quality Manager in the analysis of equipment validation testing.
  • Perform performance qualification tests on live shipments.
  • Assist in the collection and review of temperature logs.
  • Assist in the filing, tracking, scanning, indexing, and control of ISO and TVP documents for their required life cycle.
  • Daily review of truck and trailer information in Intrans.
  • Monitor shipments for ISO 28000:2007 SMS purposes.
  • Write professional letters reporting deviation findings for customers as needed by the Life Sciences Quality Manager.
  • Respond to LFS customer requests or complaints and communicate via telephone or email with customer to share data, findings, or resolutions efficiently and effectively.
  • Participate in external customer audits.
  • Assist in troubleshooting equipment failures or problems to help the department determine best resolution or repair to minimize impact on customers.
  • Identify and address non-compliance issues with contractors and communicate such deficiencies with the contractors.
  • Coach contractors to mitigate the recurrence of non-compliance issues.
  • Maintain on-call availability for after-hours events that require time-sensitive follow up when LFS QM is unavailable.
  • Use judgment on escalating problems to the LFS Operations Manager or LFS Quality Manager.
  • Other duties as assigned.

Qualifications

Required Education, Experience, Certification, Licenses, Registration:

  • High school diploma or equivalent
  • Bachelor’s Degree preferred
  • Previous work experience with technical temperature controlled equipment
  • At least 2 years of experience working in the Life Sciences department or equivalent external experience
  • GXP, FDA, Quality or Validation field preferred

                                                                                

Knowledge, Skills, & Abilities:

  • Working knowledge of Microsoft Office products (Outlook, Word, Excel, PowerPoint)

 

  • Knowledge of LFS TVP requirements, Intrans, Project Management, ISO 28000:2007, ISO 9001, ASQ.
  • Knowledge of departmental regulations (FDA and 21 CFR).
  • Ability to run reports and analyze data.
  • Ability to work independently
  • High level of problem solving ability
  • Attention to detail – concerned with implication of the smaller details of task, result, project, or course of action; and ensures that requirements are met for the successful completion of the larger objective.
  • Ability to handle multiple tasks at a time in order to accomplish daily work objectives. Considers different and new ways of doing things and is willing to modify ones preferred way of doing things.
  • Effective verbal and written communication skills.

 

Reasonable Accommodation Statement:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable qualified individuals with disability to perform the essential functions.

 

The company has reviewed this job description to ensure that essential functions and basic duties have been included. It is intended to provide guidelines for job expectations and the employee's ability to perform the position described. It is not intended to be construed as an exhaustive list of all functions, responsibilities, skills and abilities. Additional functions and requirements may be assigned by supervisors as deemed appropriate. This document does not represent a contract of employment, and the company reserves the right to change this job description and/or assign tasks for the employee to perform, as the company may deem appropriate

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