Document Specialist
Ventura Solutions Inc., Franklin, MA, United States
Are you a Document Specialist looking for a part-time contract role? The Documentation Specialist is responsible for acting as a System Administrator for the maintenance (upkeep, configuration, and reliable operation) of our eQMS and MasterControl. The Documentation Specialist position consists of managing and maintaining quality documents and records within MasterControl. This includes performing activities associated with module configuration, testing, user training, and deployment, as well as routine maintenance, use, support and troubleshooting. The Documentation Specialist is responsible for providing support to the other Document Control staff for both digital and paper-based functions carried out within Document Control as assigned by Management.
Responsibilities
Help maintain and update procedures relevant to the use and maintenance of MasterControl. Resolve Subsystem Administrator (e.g. Document Module Sub Admin, Training Module Sub Admin, etc.) and end-user issues within MasterControl (via the use of MasterControl Technical resources as needed). Ensure efficient operation of MasterControl modules, evaluate and recommend process improvements/relevant upgrades as needed. Assess software upgrades, version changes, etc. to determine impact, validation, and/or training requirements. Generate and create reports within MasterControl to ensure optimal use. Create and maintain MasterControl users/permissions. Assist with the implementation of new modules or upgrades within MasterControl. Train employees on MasterControl use, including acceptable use according to approved processes and procedures. Perform various duties in the Document Control process according to the company's SOPs relating to the life-cycle of Quality documents, associated records and training. Coordinate with all departments of the company in order to ensure the safe and secure storage and orderly maintenance of controlled documents. Post changes to electronic or paper-based records, release documents, and notify affected departments. Maintain related files. Responsible for prompt and professional communication with staff regarding quality document matters. Confer with document originators to resolve discrepancies and compile required changes to documents. Maintain master files of hard and electronic copies of procedures and related documents. Interfaces with other department managers, laboratory, and operational departments as needed. Maintains a pleasant, cooperative, and respectful relationship with co-workers and all staff. Other duties assigned by management. Qualifications
High School Diploma or equivalent, technical or computer technologies focus a plus. Bachelor's Degree preferred 2 years of database management, and/or document control experience. Subject Matter Expert of Master Control is a must Working in regulated industry (FDA, ISO, MDR/IVDR) Knowledge of Windows 10 and Microsoft Office Detail oriented with good organizational and communication skills Analytical thinking, excellent problem-solving skills Thrives in a fast-paced, collaborative environment, efficiently works under pressure, within deadlines or other time essential constraints Excellent communication skills, both written and verbal, to clearly and concisely communicate to all levels of the organization Strong work ethic and an ability to excel within a rapidly changing and growing organization Location
Franklin, MA Employment Type
Three Month Contract Part-time (about 20 hours a week) Compensation and Benefits
$25/hr.
About Ventura Solutions
Ventura Solutions is a reputable end-to-end medical device and combination product consulting, staffing, and training firm. With our deep industry expertise spanning medical devices and combination products, coupled with an outstanding talent pool, we stand out as the preferred option for a diverse array of projects. On the consulting side, we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects. On the staffing side, we help source, screen, and on-board reputable employees to fill temporary, temp to permanent, and permanent job openings. We accelerate product development, keep products compliant, and help build great organizations. For more information, visit us at www.ventura-solutions.com.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
Responsibilities
Help maintain and update procedures relevant to the use and maintenance of MasterControl. Resolve Subsystem Administrator (e.g. Document Module Sub Admin, Training Module Sub Admin, etc.) and end-user issues within MasterControl (via the use of MasterControl Technical resources as needed). Ensure efficient operation of MasterControl modules, evaluate and recommend process improvements/relevant upgrades as needed. Assess software upgrades, version changes, etc. to determine impact, validation, and/or training requirements. Generate and create reports within MasterControl to ensure optimal use. Create and maintain MasterControl users/permissions. Assist with the implementation of new modules or upgrades within MasterControl. Train employees on MasterControl use, including acceptable use according to approved processes and procedures. Perform various duties in the Document Control process according to the company's SOPs relating to the life-cycle of Quality documents, associated records and training. Coordinate with all departments of the company in order to ensure the safe and secure storage and orderly maintenance of controlled documents. Post changes to electronic or paper-based records, release documents, and notify affected departments. Maintain related files. Responsible for prompt and professional communication with staff regarding quality document matters. Confer with document originators to resolve discrepancies and compile required changes to documents. Maintain master files of hard and electronic copies of procedures and related documents. Interfaces with other department managers, laboratory, and operational departments as needed. Maintains a pleasant, cooperative, and respectful relationship with co-workers and all staff. Other duties assigned by management. Qualifications
High School Diploma or equivalent, technical or computer technologies focus a plus. Bachelor's Degree preferred 2 years of database management, and/or document control experience. Subject Matter Expert of Master Control is a must Working in regulated industry (FDA, ISO, MDR/IVDR) Knowledge of Windows 10 and Microsoft Office Detail oriented with good organizational and communication skills Analytical thinking, excellent problem-solving skills Thrives in a fast-paced, collaborative environment, efficiently works under pressure, within deadlines or other time essential constraints Excellent communication skills, both written and verbal, to clearly and concisely communicate to all levels of the organization Strong work ethic and an ability to excel within a rapidly changing and growing organization Location
Franklin, MA Employment Type
Three Month Contract Part-time (about 20 hours a week) Compensation and Benefits
$25/hr.
About Ventura Solutions
Ventura Solutions is a reputable end-to-end medical device and combination product consulting, staffing, and training firm. With our deep industry expertise spanning medical devices and combination products, coupled with an outstanding talent pool, we stand out as the preferred option for a diverse array of projects. On the consulting side, we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects. On the staffing side, we help source, screen, and on-board reputable employees to fill temporary, temp to permanent, and permanent job openings. We accelerate product development, keep products compliant, and help build great organizations. For more information, visit us at www.ventura-solutions.com.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled