Store, manage EDMS (MasterControl), and track company documents including, but not limited to, drawings, training records, SOP’s, customer and specifications.
ESSENTIAL DUTIES AND RESPONSIBILITIES (Other duties may be assigned)
Manage and maintain documents in MasterControl.
Assess document packets in MasterControl to ensure compliance to applicable procedures, including document template, reviewer selection, appropriate change justification, training plan, etc.
Assist in preparing reports regarding quality and training activities.
Provides/resets passwords for MasterControl access
Maintain paper-based documentation including distribution and filing (e.g. SOP Books).
Manage and maintain public organizers in MasterControl.
Maintain job code, course, and trainee data in MasterControl.
Manage digital and paper training folders.
Support external audits, assisting with activities in backroom, and ensuring timely response to documentation requests for auditors.
Investigate and assist in responding to corrective actions related to quality system training.
Assist engineering personnel in preparation, revision, routing and distribution of quality system documentation and procedures.
Support user requests for documentation and trains users in MasterControl as needed.
File, log and reconcile various logs to track and disposition documents such as engineering studies (EST’s), validations, pFMEA’s, control plans.
Responsible for ensuring the administration of MasterControl including working with the provider to troubleshoot system issues, improving and adding workflows, as required, creating new document types and templates, generating and performing user training, setting up and generating reports/ad-hoc reports, and supporting upgrades/expanded use. 'Championing’ the use of MasterControl and engaging with the user community to identify continual improvement opportunities.
Supports and advise end users on document system requirements and workflows
Posts changes to computerized or manual control records, releases documents, and notifies affected departments.
Generate weekly reports for capital projects, and provide data to Customer Service Manager for invoicing R&D projects.
Serve as back-up to reception/phone operator.
Adhere to all Company policies, rules, procedures and housekeeping standards.
Participate in quality and process improvement initiatives and project teams.
Follows the official policy for Good Manufacturing Practices as required in the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act
Provide feedback and pro-active communication to supervisor, management, and co-workers to help ensure efficient and effective operations. Contribute input to management based on knowledge of processes toward process and product improvement efforts of the company.
- Perform other projects and duties that may be assigned, as deemed necessary, by the supervisor.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
Two year certificate from college or technical school; or 3 years related experience and/or training; or equivalent combination of education and experience. Requires extensive experience with Personal Computers and Microsoft Office Software. Prior related experience preferred.
CERTIFICATES, LICENSES, REGISTRATIONS, OTHER SKILLS AND ABILITIES
Any certifications in front office administrative tasks will be considered. Experience with online collaboration and networking tools will be considered.
To perform this job successfully, an individual should have thorough working knowledge of Microsoft® Word. Experience with other accounting and desktop publishing software applications; Microsoft® Excel, Access, Power Point, Crystal Reports®, Adobe® Acrobat. The individual must be computer literate and adapt at learning new software applications. The individual must be familiar with integrating multimedia files for the purpose of illustrating documents.
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. Must have grammar skills to effectively correct own work and work of others.
Simplistic mathematical skills for addition, subtraction multiplication and division.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is frequently required to sit and talk or hear. The employee is occasionally required to walk and use hands to finger, handle, or feel. The employee must occasionally lift and/or move up to 10 pounds.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually moderate.