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Tech Observer · 1 day ago

Quality Systems Specialist

Exton, PA

Contract

Hybrid

Mid Level

$45/hr - $46/hr

3+ years exp

Tech Observer is seeking a Quality Systems Specialist to support regional quality systems activities ensuring compliance with cGMPs and regulatory requirements. This role involves managing SOPs, inspection readiness, quality metrics, and collaborating with cross-functional teams to drive quality improvement.

BiotechnologyLife SciencePharmaceutical

No H1B

Hiring Manager

Brian Joel

Responsibilities

Perform core regional quality systems activities, including SOP revisions and inspection readiness support, in accordance with established procedures

Develop, improve, and maintain regional quality system SOPs and related documentation

Analyze, track, and report key quality and risk metrics; recommend and support corrective actions

Monitor quality systems to identify gaps, escalate issues, and support timely resolution

Provide project management support for quality systems initiatives and collaborate with cross-functional teams to achieve quality objectives

Qualification

CGMP knowledgeQuality systems experienceSOP writingMetrics monitoringEffective communication

Required

Prior cGMP and Quality experience required (local candidates only)

Experience – 3 – 5 Years

Bachelor's degree in Chemistry, Biochemistry, or a related technical discipline

Minimum 3 years of relevant experience in quality systems (e.g., audits and regulatory inspections, LMS/training operations, document control, electronic quality systems)

Strong knowledge of cGMPs and applicable health authority and regional guidelines

Hands-on experience executing quality processes, including SOP/protocol writing, metrics monitoring, and issue resolution

Demonstrated strong performance in prior roles