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Job DescriptionJob Description

Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services while treating candidates with the professionalism and respect they deserve.


Associate II, QCSM (Quality Control Sample Management)

Shift: 2nd shift, Wednesday through Saturday 2pm - 12am

 
Notes-

  • Looking for QC GMP background, ideally in sample management, but microbiology or manufacturing backgrounds are good as well.
  • Ideally looking for someone with 6mos-1 year experience. 
  • Not looking for someone high level (previous manager level titles, engineers, etc.)
  • One and done 30 min video interview to hire 


The Role
Seeking a contract role in Quality Control Sample Management Associate II.  The individual in this role will perform cGMP QC sample management activities for QC Chemistry, Microbiology, Bioassay, and various Development labs.

Here’s What You’ll Do:

  • Sample coordination including cross functional collaboration with internal and external labs
  • Receipt, processing, distribution and shipment of the following sample types:
    • In-Process, DS, Formulation and DP
    • Equipment cleaning
    • Stability
    • Raw Materials
  • Coordinating domestic and international sample shipments
  • Communication with external Contract Test Labs (CTLs)
  • Interact with Development teams in a GMP compliant manner
  • Inspect product and raw material retention samples
  • LIMS (LabVantage) sample logging and result entry
  • AQL visual inspection of drug product
  • Stability program support
  • Controlled temperature unit management, maintenance and troubleshooting
  • Clean room gowning
  • Managing/stocking of QC lab supplies
  • Write/revise SOPs, protocols and reports
  • Complete and maintain cGMP documentation for work performed
  • Participate in authoring quality systems records such as deviations, change controls, CAPAs
  • Support non-conformance investigations
  • Establish and maintain a safe laboratory working environment
  • This position will support first shift QC Sample Management operations from Wednesday  through Saturday
  • Additional duties as may be assigned from time to time


Here’s What You’ll Bring to the Table:

  • Education: Bachelor’s degree in a relevant scientific discipline
  • Experience: At least two years in a cGMP laboratory setting
  • Demonstrated aptitude or ability to learn in order to gain a strong understanding of GxP regulations.
  • General laboratory operations (Pipette and analytical balance use.)
  • Strong technical writing skill
  • Proficiency with Microsoft Office Programs
  • Quick learner with electronic databases (e.g. LIMS, SAP, LMS)
  • Strong written and oral communication skills as well as organizational skills
  • General knowledge of industry standards and guidelines for quality control laboratory operation
  • Demonstrated ability to work effectively under established guidelines and instructions
  • Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
  • Be able to follow the relevant Standard Operation Procedures as written.
  • Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment.
  • A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

 

Company DescriptionConnexion Systems & Engineering is a full-service staffing firm, whose mission is to provide "best in class" staffing services to our clients and job seekers alike. We strive to achieve excellence in staffing, job placement and recruiting services, while treating our clients, employees, and candidates with the professionalism and respect they deserve.Company DescriptionConnexion Systems & Engineering is a full-service staffing firm, whose mission is to provide "best in class" staffing services to our clients and job seekers alike. We strive to achieve excellence in staffing, job placement and recruiting services, while treating our clients, employees, and candidates with the professionalism and respect they deserve.