Act as SME for Document Control; own lifecycle of quality processes/records
System Administrator for eDMS; manage config, users, lifecycle, and improvements
Provide quality oversight on regulated activities and deliverables (process, validation, releases)
Interpret and advise on federal regulations and quality system requirements
Develop metrics and track effectiveness of domain systems

🎯 Requirements

BS/BA in Science, Information Management, Engineering, or related field
5+ years experience in a regulated quality role in Life Sciences
Experience with QMS (documentation/records, training, change control, CAPA)
Experience with eDMS and/or eQMS
GxP regs (GMP, GCP) and QMS standards (21 CFR 11, ICH Q10, QSR); ISO 9001
Excellent process mapping, problem-solving, and communication skills

🎁 Benefits

Medical, dental, vision, and basic life insurance
Flexible PTO and company paid holidays
Retirement programs
1% charitable giving program

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