Manufacturing Quality Assurance Engineer - (Night Shift)
Core
Ensuring product compliance with internal standards and external regulations (e.g., FDA, ISO) during oligonucleotide production facility operations.
Role type
Manufacturing Quality Assurance Engineer
Builds
Oligonucleotide therapeutics for life-saving medicines
Domain
Biopharma / GMP-regulated manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP standards knowledge, batch record review, real-time floor operations support, multi-functional collaboration, internal audit support, process improvement, problem-solving
Preferred skills
Oligonucleotide manufacturing experience, post-graduate certification or license
Technologies
None stated
Responsibilities
Provide real-time on-the-floor quality support during manufacturing operations, Review executed batch records and in-process documentation, Collaborate with Manufacturing, Materials, Quality Control, Engineering, and Facilities teams, Contribute to problem-solving efforts and process improvements, Support internal audits and documentation practices, Participate in on-call rotational schedule
Seniority
Mid-level, hands-on IC