Quality Assurance Specialist I, Document Control and Training

This is a fully remote position, open to applicants in United States.

📋 Description

• Manage and monitor the processing, review, approval, archival, and distribution of revision-controlled documents within the Electronic Document Management System (eDMS) independently.

• Provide support and guidance to users regarding document workflows, processes, and system utilization.

• Ensure all documents comply with formatting, content, and regulatory standards prior to receiving approval.

• Maintain accurate, complete, and traceable document records within the system.

• Coordinate periodic reviews of controlled documents to guarantee ongoing accuracy and compliance.

• Assist in internal and external inspections by retrieving necessary documentation and ensuring readiness for inspections.

• Independently oversee training assignments and task execution within the Electronic Document Management System (eDMS).

• Generate and distribute reports on training compliance for management and auditing purposes.

• Support onboarding training activities and the assignment of required curricula.

• Identify and escalate inefficiencies in document control and training workflows.

• Carry out miscellaneous duties as assigned.

⛳️ Requirements

• A Bachelor’s degree in a Life Sciences discipline is preferred, but not mandatory.

• A minimum of two (2) years of experience in QA training and documentation within a pharmaceutical or biopharmaceutical GMP facility. Experience in other Quality areas (Quality Operations and/or Quality Systems) is a plus.

• Must demonstrate a high level of attention to detail and proficiency in Microsoft Word.

• Strong computer, organizational, and compliance skills are required.

• Proficient in an eDMS/eLMS system (specifically MasterControl); experience as a MasterControl System Administrator or Document Control Administrator is advantageous.

• Familiarity with document change management and FDA quality systems is necessary.

• Ability to effectively manage multiple projects simultaneously with minimal supervision.

• Strong interpersonal and communication skills are essential.

🏝️ Benefits

• Reasonable accommodations may be provided upon request to enable individuals to perform essential functions.