Author and lead deviation investigations, nonconformance reports, and technical assessments across manufacturing, engineering, and supply chain functions
Gather, analyze, and interpret data to determine root cause using tools such as Fishbone and 5 Whys
Partner with subject matter experts to develop effective corrective and preventative actions (CAPAs)
Translate complex technical scenarios into clear, concise, and audit-ready documentation
Identify trends across deviations, nonconformances, and quality events to support continuous improvement initiatives
Manage controlled documentation within the eQMS, including SOPs, work instructions, specifications, and batch records
Issue, reconcile, and review GxP documentation to ensure compliance with internal standards and regulatory requirements
Support document lifecycle processes including revision control, training assignments, and document archival
Serve as a resource for document control systems and provide guidance to internal stakeholders
Support core Quality Management System (QMS) processes including Change Control, CAPA, and Deviation review
Assist with tracking and reporting of quality metrics and KPIs
Participate in audit and inspection readiness activities, including documentation support and CAPA follow-up
Drive continuous improvement efforts related to documentation processes and QMS efficiency
Qualifications
Bachelor’s degree in a scientific, engineering, or technical discipline (or equivalent experience) 2–5+ years of experience in a GMP-regulated environment (pharmaceutical, biotech, or medical device preferred) Strong technical writing experience (deviations, investigations, SOPs, specifications, or document control) Working knowledge of cGMPs, Good Documentation Practices (GDP), and Quality Systems (CAPA, Change Control, Document Control) Experience with electronic Quality Management Systems (eQMS/EDMS) Proficiency in Microsoft Word and Excel Strong analytical, organizational, and problem-solving skills Ability to work both independently and cross-functionally in a fast-paced environment Effective written and verbal communication skills
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Bachelor’s degree in a scientific, engineering, or technical discipline (or equivalent experience) 2–5+ years of experience in a GMP-regulated environment (pharmaceutical, biotech, or medical device preferred) Strong technical writing experience (deviations, investigations, SOPs, specifications, or document control) Working knowledge of cGMPs, Good Documentation Practices (GDP), and Quality Systems (CAPA, Change Control, Document Control) Experience with electronic Quality Management Systems (eQMS/EDMS) Proficiency in Microsoft Word and Excel Strong analytical, organizational, and problem-solving skills Ability to work both independently and cross-functionally in a fast-paced environment Effective written and verbal communication skills
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