Quality Assurance Project Specialist

Overview

On Site
Hybrid
$35 - $40
Contract - W2
Contract - 15 Month(s)
No Travel Required

Skills

Change Control
ISO 9000
GMP
Quality Assurance
Quality Control
SAP QM
Quantum Mechanics
SOP
OQ
Quality Management

Job Details

Trident Consulting is seeking a "Quality Assurance Project Specialist (QA Liaison) for one of our clients. A global leader in business and technology services.

 

Role: Quality Assurance Project Specialist (QA Liaison)

Location: 6000 N Teutonia, Milwaukee, WI

Job Type : Contract

Duration: 15 months (likely temp only)

Work Type:  40 hrs/week (8.5 hrs/day including break)

Start Time: 6AM 9AM

Interview: On-site

Work Model: 100% onsite initially possible 2 3 days hybrid after training

Pay: $35 $40/hr on w2

 

Core Purpose of the Role

Serve as the Quality Assurance Project Specialist / QA Liaison supporting Quality Systems, audits, CAPA, change controls, training, data integrity, calibration programs, and overall compliance with GMP, Corporate Policies, and ISO standards.

Mandatory Experience & Systems

  • GMP experience (preferred but highly relevant)
  • SAP (QM preferred)
  • TrackWise or equivalent QMS
  • Mango or equivalent LMS
  • MS Office Suite
  • ISO 9001 experience

Preferred:

  • Power Apps

Education Requirements

Any of the following:

  • Bachelor s in Chemistry or Life/Physical Sciences
  • Associate degree + 6 years experience
  • High school diploma + 6 years relevant experience

 

Key Responsibilities

  1. Instrument Calibration Program
  • Maintain calibration schedules
  • Manage onboarding, IQ/OQ, retirement documentation
  • Keep LIMS equipment data accurate
  • Coordinate calibration task execution
  • Support out-of-calibration investigations
  • Review calibration and quality documents
  1. Data Integrity Program
  • Conduct GDP audits
  • Ensure compliance with Data Integrity guidelines
  • Work with metrologist/digital liaison

 

  1. Customer Complaints & Audit Response
  • Oversee CAPA investigations
  • Lead complaint investigations & communicate with customers
  • Respond to audit findings
  • Provide resolutions and documentation
  1. Change Control Gatekeeping
  • Review change requests
  • Ensure compliance with global/local/customer requirements
  • Support other departments with CC queries
  1. Procedure Development & Documentation
  • Write/modify SOPs
  • Manage SOP review cycles
  • Identify and document process improvement opportunities
  • Act as change agent to improve quality compliance and productivity
  • Provide technical & regulatory reviews
  1. Support Local Quality System Projects
  • Improve processes via scientific knowledge
  • Coordinate QC experiments
  • Support non-conformance investigations
  • Communicate risks & roadblocks to management
  1. Audit Participation
  • Participate in internal, customer & regulatory audits
  • Provide accurate records
  • Provide explanations, solutions & support process improvements
  1. Training Responsibilities
  • Train QC staff and new QA liaisons
  • Provide monthly training sessions
  • Mentor team members on policies, procedures, and quality topics

Required Skills

  • Strong understanding of Quality Systems and ISO regulations
  • SAP proficiency (especially QM)
  • Excellent documentation, organization & project management
  • Communication skills (written + verbal)
  • Troubleshooting and problem-solving
  • Computer proficiency across multiple systems

Safety & Physical Requirements

  • No heavy lifting
  • No exposure to chemicals requiring PPE
  • No respiratory, laser, or biological hazards
  • No forklift operation
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