Quality Assurance Project Specialist
1 week ago
Role: Quality Assurance Project Specialist (QA Liaison)Location: 6000 N Teutonia, Milwaukee, WIJob Type : Contract - W2Duration: 15 months (likely temp only)Work Type: Full-time, 40 hrs/week (8.5 hrs/day including break)Start Time: 6AM-9AMInterview: On-siteWork Model: 100% onsite initially → possible 2-3 days hybrid after trainingPay: $35-$40/hr on w2Core Purpose of the RoleServe 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 experiencePreferred:• Power AppsEducation RequirementsAny of the following:• Bachelor's in Chemistry or Life/Physical Sciences• ssociate degree + 6 years experience• High school diploma + 6 years relevant experienceKey Responsibilities1. 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 documents2. Data Integrity Program• Conduct GDP audits• Ensure compliance with Data Integrity guidelines• Work with metrologist/digital liaison3. Customer Complaints & Audit Response• Oversee CAPA investigations• Lead complaint investigations & communicate with customers• Respond to audit findings• Provide resolutions and documentation4. Change Control Gatekeeping• Review change requests• Ensure compliance with global/local/customer requirements• Support other departments with CC queries5. Procedure Development & Documentation• Write/modify SOPs• Manage SOP review cycles• Identify and document process improvement opportunities• ct as change agent to improve quality compliance and productivity• Provide technical & regulatory reviews6. Support Local Quality System Projects• Improve processes via scientific knowledge• Coordinate QC experiments• Support non-conformance investigations• Communicate risks & roadblocks to management7. Audit Participation• Participate in internal, customer & regulatory audits• Provide accurate records• Provide explanations, solutions & support process improvements8. Training Responsibilities• Train QC staff and new QA liaisons• Provide monthly training sessions• Mentor team members on policies, procedures, and quality topicsRequired 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 systemsSafety & Physical Requirements• No heavy lifting• No exposure to chemicals requiring PPE• No respiratory, laser, or biological hazards• No forklift operation
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