Senior QA & Quality Systems Specialist (Onsite)

Kelly Services; Gaithersburg (MD); On-site; USD 146,000 - 177,000; Full time

Job summary

Kelly Science & Clinical is seeking a Senior Quality Assurance / Quality Systems consultant for an onsite contract in Gaithersburg, MD. The role targets 8+ years in QA/QS within a regulated life sciences setting and involves CAPA, change control, audits, supplier quality, and regulatory readiness.

The position offers a 3–6 month contract, 40 hours per week, day shift, with a pay rate of $70–$85 per hour. No supervisory responsibilities are included, and FDA readiness support is expected.

Qualifications

• 8+ years of experience in Quality Assurance and/or Quality Systems.
• Experience in GxP-regulated pharmaceutical, biotech, medical device, or life sciences environments.
• Strong knowledge of CAPA, change control, audits, supplier quality and document management.
• Experience reviewing and approving validation and quality documentation.

Responsibilities

• Review and close change controls, including client notifications.
• Assess and approve CAPAs and effectiveness checks.
• Review and approve documents within the eQMS (validation docs, risk assessments, SOPs, QC specs, method validations, facility validations, EMPQ, APS, other docs).
• Conduct supplier quality audits and review supplier change notifications.
• Perform internal audits and evaluate supplier-initiated notifications.
• Support FDA readiness activities with gap assessments and cross-functional remediation.

Skills

Quality Assurance

Quality Systems

FDA readiness

Tools

eQMS

Job description

Kelly Science & Clinical is seeking a Senior Quality Assurance / Quality Systems consultant for an onsite contract in Gaithersburg, MD. The role targets 8+ years in QA/QS within a regulated life sciences setting and involves CAPA, change control, audits, supplier quality, and regulatory readiness.

The position offers a 3–6 month contract, 40 hours per week, day shift, with a pay rate of $70–$85 per hour. No supervisory responsibilities are included, and FDA readiness support is expected.