Product Quality Engineer
Core
Ensuring compliance, reliability, and continuous improvement of manufacturing and analytical processes in life sciences and diagnostics.
Role type
Product Quality Engineer
Builds
compliant manufacturing and analytical methods for life sciences products
Domain
Life Sciences / Diagnostics / GMP Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP guidelines knowledge, regulatory requirements interpretation, API manufacturing/testing process expertise, change control management, risk management, validation, design control, nonconformance handling, QMS documentation review, audit coordination, continuous improvement initiatives
Preferred skills
oligonucleotide manufacturing experience, pharmaceutical manufacturing experience
Technologies
Microsoft Office
Responsibilities
Serve as Quality Assurance lead on product and analytical method development projects; Support compliance activities related to change control, risk management, validation, design control, and nonconformance handling; Collaborate with clients and internal teams to define roles and responsibilities, and negotiate and implement Quality Technical Agreements (QTAs); Participate in audits and regulatory inspections, coordinating response efforts; Review and approve quality documentation, including change controls, SOPs, batch records, analytical reports, specifications, nonconformances, and CAPAs; Provide training and consultative support on quality systems and processes; Drive continuous improvement initiatives within the QMS; Respond to customer inquiries and regulatory requests; Support Pre-Approval Inspection (PAI) readiness
Seniority
Mid-level, hands-on IC
