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Lead QA Technician - 1st Shift

Rockville, Maryland, USA💼 Full-time💰 $26–$26🗓 2026-08-25 → 2026-09-25

Core

Lead QA Technician ensuring product quality and regulatory compliance in pharmaceutical manufacturing operations.

Role type

Lead QA Technician (Pharmaceutical Manufacturing)

Builds

Pharmaceutical products and life-changing medicines

Domain

Pharmaceutical manufacturing / Quality Assurance

Deliverable

production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work

Required skills

GMP compliance, batch record review, quality documentation systems (TrackWise, Documentum), label/CoA/CoC control, regulatory inspection support, root cause analysis, technical procedure interpretation

Preferred skills

Chemistry, Pharmacy, Biology, Biotechnology background

Technologies

TrackWise, Documentum, Microsoft Office

Responsibilities

Assure activities align with batch records, SOPs, GMP, and DEA regulations; Conduct critical reviews of GMP documentation; Review online batch records for completeness; Approve and control labels, CoA, and CoC documentation; Support regulatory inspections and customer audits; Review documents completed by operations personnel.

Seniority

Mid-level, hands-on IC

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