Quality Control Specialist

Overview

On Site
$33.33 - $36.36 hr
Contract - W2
Contract - Independent
Contract - 12+ mo(s)

Skills

QUALITY CONTROL
LIMS
CSV
COMPUTERIZED
LMES
SMARTLAB
LAB SYSTEMS
LABORATORY SYSTEMS
GMP
ELN
ELECTRONIC LAB NOTEBOOK
IMPLEMENTATION
IMPLEMENTED
IMPLEMENT
IMPLEMENTING

Job Details

Payrate: $33.33 - $36.36/hr.

Summary:
The ideal candidate will have at least 4 years of experience supporting the implementation or validation of electronic quality systems, preferably within a GMP-regulated pharmaceutical or medical device environment. They should be comfortable working independently, possess strong technical documentation skills, and have hands-on experience building, configuring, or validating systems, not just using them. Prior involvement in global or cross-functional IT system projects is preferred.

This position will support QC ELN Project, including but not limited to, system validation/qualification deployment, eProcedure qualification, instrument report parsing script qualification and masterdata templating associated with Laboratory System Upgrade (CIMS (Reagent Manager)/LMES (Smart Lab eProcedure).

Responsibilities:
  • Support validation/qualification deployment
  • Lead eProcedure qualification in LMES in support of Global QC Method Specific eProcedure creation/qualification project.
  • Manage CIMS template creation for Global QC method specific reagents/ and ANC consumables.
  • Provide incident management support as required.
  • Support application performance monitoring and label printing issues.
  • Identify operational gaps and propose solutions.
  • Assist in the execution of QC Laboratory Systems equipment integration for all ANC QC Laboratories.
  • Responsible for training the NC site as each QC Laboratory systems go live in the production environment.
  • Author, revise, and review documents and reports including SOPs, qualification reports, technical reports.
  • Lead planning, scheduling, and execution of QC Laboratory Systems daily activities.

Top 3 Must Have Skill Sets:
  • Experience with implementing new computerized laboratory systems.
  • Leadership experience
  • Ability to work independently

Pay Transparency: The typical base pay for this role across the U.S. is: $33.33 - $36.36/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.

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