Aesculap, Inc., a B. Braun company, is part of a 180-year-old global organization focused on meeting the needs of an ever-changing healthcare community. Through close collaboration with its customers, Aesculap provides advanced technologies for general surgery, neurosurgery and closure technologies. Aesculap continues a proud heritage of leadership and responsiveness as we strive to deliver products and services that improve the quality of patients' lives.
The Senior Quality Assurance (QA) / Document Control (DC) Associate will be responsible for the Electronic Document Management System (EDMS) and Electronic Training System (ISO-train). This position is responsible for the documentation supporting product safety and quality and has a direct impact on patient safety. All job functions must be carried out responsibly, competently, and conscientiously to ensure that Aesculap Biologics' products are safe and effective.
Principal Duties Responsibilities:
Develops, implements, and maintains the Aesculap Biologics' Electronic Document Management System in support of GXP compliance. This includes control and the appropriate retention of Quality records and GXP documentation.
Develops, implements, and maintains the Aesculap Biologics' Electronic Training System in support of GXP compliance.
Subject matter expert on the Electronic Document Management System and Electronic Training Systems.
Provides training and technical support to all AB staff on the Documentation and Training Systems.
Provide metrics and reports on Documentation and Training Systems.
Controls, archives and maintains documentation, labeling, and records using periodic audits to insure a state of compliance.
Assists in developing and implementing GXP Training for Aesculap Biologics staff. Provides oversight of training records management. Assists in the development, presentation and recording of training.
Creates, distributes, and tracks labeling, logbooks, and quality records in a secure and compliant manner.
Ensures that controlled documents and records are accessible to staff in electronic format and paper hardcopy (as required).
Writes and reviews SOPs, job aids, process flows, and other documents in compliance with relevant federal and state regulations.
May interact with federal and state health authorities as Subject Matter Expert for the Documentation and Training Systems.
Prepares materials for and participates in Management Review activities.
Provides oversight for record keeping activities to ensure records completion and security.
Must be available weekends and holiday hours (as required).
Must comply with applicable GMP and FDA regulations as stated in Quality Manual.
Must embody the Company's Vision, Mission, Values, and cultural beliefs.
Associates degree and 4-6 years of QA Document control / GMP training experience in Pharmaceutical, Biotech, or Medical Device industry.
Experience with electronic document management systems (EDMS, Live Link, Master Control, Documentum) and electronic training systems (ISOtrain), is required.
SAP experience is a plus
Excellent command of the English language.
Intermediate knowledge of Microsoft Office Products including OneDrive, OneNote, SharePoint, Visio, Project, Power Point and Adobe Pro to support document preparation and presentations.
Excellent oral and written communication skills required with the ability to communicate at all levels of the organization.
Must have strong organizational skills and provide positive customer service for all internal and external customers.
Must be detail oriented and have a good understanding of GMP documentation requirements.
Must be able to work independently.
Language and mathematical skills; reasoning ability:
Language Skills: Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to effectively present information to top management, public groups, and/or boards of directors.
Mathematical Skills: Ability to add, subtract, multiply, divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
Reasoning Ability: Ability to define problems, collect date, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. . The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.