Senior QA & Quality Systems Consultant — Onsite

Kelly Services; Gaithersburg (MD); On-site; USD 96,000 - 105,000; Full time

Job summary

Kelly Science & Clinical seeks a Senior Quality Assurance / Quality Systems professional for an onsite contract in Gaithersburg, MD. The ideal candidate has 8+ years in QA/QS, with strong CAPA, change control, audits, supplier quality, and FDA readiness experience.

The role is contract-based (3–6 months) with a 40-hour week, day shift, and no supervisory responsibilities. This position supports regulated life sciences activities and regulatory readiness efforts.

Qualifications

• 8+ years of experience in Quality Assurance and Quality Systems.
• Experience in GxP-regulated environments (pharma/biotech/medical devices).
• Strong knowledge of CAPA, change control, audits, supplier quality, and document management.

Responsibilities

• Review and close change controls and client notifications.
• Assess and approve CAPAs and effectiveness checks.
• Review and approve eQMS documents including validation docs, SOPs, QC specs, and method/facility validations.
• Conduct and support supplier quality audits and supplier change notifications.

Skills

Quality Assurance

Quality Systems

Regulatory readiness

CAPA

Audits

eQMS

Job description

Kelly Science & Clinical seeks a Senior Quality Assurance / Quality Systems professional for an onsite contract in Gaithersburg, MD. The ideal candidate has 8+ years in QA/QS, with strong CAPA, change control, audits, supplier quality, and FDA readiness experience.

The role is contract-based (3–6 months) with a 40-hour week, day shift, and no supervisory responsibilities. This position supports regulated life sciences activities and regulatory readiness efforts.