Quality Control Logistics Lead

Overview

Summary:  The Quality Control Logistics Lead will be responsible for coordinating and overseeing all aspects of Quality Control (QC) equipment procurement, installation, and qualification.  This position will require the candidate to work closely with QC, QA, Validation, Engineering, and Facility staff members to coordinate and track all activities required to bring QC equipment into a GMP compliant state.  

External US

Essential Functions:

  • Liaison between the QC Department and Capital Projects Team
  • Coordinate and oversee annual PM calibrations for QC equipment
  • New equipment induction into Blue Mountain Ram (BMR); submit work orders in BMR
  • Work with Metrology to facilitate monthly calibration of QC equipment
  • Generate and manage Change Controls for new equipment installations, equipment relocation, and software upgrades as required
  • Assist with Equipment Out of Tolerance (OOT) and missing portable equipment deviations
  • Coordinate onsite visits with equipment vendors; serve as QC lab escort, and facilitate vendor Good Documentation Practices (GDP) training with QA
  • Author User Requirement Specification (URS) criteria for new QC equipment as needed
  • Generate and maintain a comprehensive QC equipment list
  • Serve as the QC Environmental Health and Safety (EHS) representative
  • Attend QC Tier Meetings to provide updates on equipment readiness
  • Assist QC Managers in eBOT purchase transactions
  • Assist in authoring and reviewing Standard Operating Procedures (SOPs) relevant to the job function
  • Assess / Monitor annual PM and calibration costs for all QC equipment to forecast QC equipment budget line item
  • General knowledge of GxP   
  • All other duties as assigned

Required Skills & Abilities:

  • Excellent oral and written communication skills as well as interpersonal and organizational skills
  • Proficient with Microsoft Office applications
  • Good self-discipline and attention to detail
  • Ability to multitask and easily prioritize work
  • Ability to work independently with little supervision
  • Must have good planning skills and a willingness to interface with internal staff and external vendors to ensure QC equipment is GMP compliant state

Working Conditions & Physical Requirements:

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 accommodations 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:

  • Experience prolonged standing, some bending, stooping, pushing, pulling, reaching above shoulders and stretching
  • Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment
  • Minor lifting up to 25 pounds may be required 
  • Attendance is mandatory

Qualifications:

  • Minimum of an Associate’s Degree or PMP certification required
  • Experience working in a GMP environment preferred

We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state, or local law. 

If an accommodation to the application process is needed, please email FDBTHR@fujifilm.com or call 979-431-3528.

 

Posted
01/02/2022
Type
Full time
Salary Range
$47,000.00 - 105,000.00
per Year
Salary range estimated by
Location
College Station, TX 77845, US
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