Quality Assurance Specialist I, Document Control and Training [Contract to Hire]

Overview

This position is responsible for supporting the Quality Document Control and Training program and ensuring compliance to quality objectives and regulatory requirements.

Essential Functions and Responsibilities

• Independently manage and monitor the processing, review, approval, archival, and distribution of revision- controlled documents in the Electronic Document Management System (eDMS).
• Provide user support and guidance on document workflows, processes, and system usage.
• Ensure documents meet formatting, content, and compliance standards prior to approval.
• Maintain document records to ensure accuracy, completeness, and traceability within the system.
• Coordinate document periodic reviews of controlled documents to ensure ongoing accuracy and compliance.
• Support internal and external inspections by retrieving documentation and ensuring inspection readiness.
• Independently manage training assignments and task execution within the Electronic Document Management System (eDMS).
• Generate and distribute training compliance reports for management and audit purposes.
• Support onboarding training activities and assignment of required curriculum.
• Identify and escalate process inefficiencies within document control and training workflows.
• Perform miscellaneous duties as assigned.

Required Education, Skills, and Knowledge

• Bachelor’s degree in Life Sciences discipline preferred, not required.
• Two (2) years in QA training and documentation in pharmaceutical or biopharmaceutical GMP based facility. Experience in other areas of Quality (Quality Operations and/or Quality Systems) is a plus.
• Must possess a high level of attention to detail and proficient in Word and
• Strong computer, organizational, and compliance skills
• Proficient in an eDMS/eLMS system (specifically MasterControl). Experience as MasterControl System Administrator or MasterControl Document Control Administrator is a plus.
• Familiarity with document change management and FDA quality systems
• Ability to work effectively on multiple projects simultaneously with minimun
• Strong interpersonal and communication skills

Physical Demands and Activities Required

• Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
• Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
• Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.