- Responsible for maintaining the eQMS system and performing tasks related to continuous improvement of this electronic QMS system.
- Develop and maintain eQMS installation and configuration management procedures.
- Following up on support issues proactively to provide timely updates and resolutions to end users.
- Provide troubleshooting expertise to end users on an ad hoc basis, consulting with the software vendor(s) as needed. Work with the vendor to troubleshoot and resolve application issues. Coordinate and communicate with impacted stakeholders as needed.
- Provide quality oversight and compliance support to implement and validate electronic systems in accordance with the corporate computer system validation (CSV) procedures and requirements
- Develop or review protocol, plans, scripts, reports, SOPs etc. associated with the implementation and maintenance of computerized systems
- Provide QA oversight during risk, Part 11 and Annex 11 and regulatory assessments
- Represent the eQMS group at cross-functional meetings
- Review changes to validated state of system through the change control and participate in planning and implementing changes
- Serve as the QA contributor on projects including inquiries pertaining to the interpretation of the FDA and other regulatory requirements for computer system validation
- Perform other quality and computer system validation duties as assigned
- Stakeholder in the development, implementation, and continued improvement of quality systems within the QA department.
- Member of a team responsible for coordinating and executing all activities necessary to maintain compliance with cGMP and/or ISO 13485 and the integrity of the Quality Management System
- Execute document and change control processes to ensure standardization, accuracy, and completeness of documents prior to release.
- Maintain controlled copies of Quality documents in the files and in electronic databases
- Facilitate document retrieval during regulatory inspections
- Perform other duties as assigned.
Required Skills & Abilities:
- Self-motivated with a drive for excellence
- Positive attitude and strong interpersonal skills
- Honesty, integrity, respect and courtesy with all colleagues
- Creative and can work with minimal supervision following internal procedures balanced with independent thinking
- Resilient through operational and organizational change
- Exceptional planning and organizational skills and the ability to multi-task and meet deadlines is required
- Requires the ability to communicate effectively using speech, vision, hearing and written word
- Must be able to walk or move or drive between locations
- Interacts with all departmental staff, including giving training and / or presentations to small and large groups
- Apply knowledge of cGMPs on a daily basis, as applicable
- Adhere to the standards of quality ruled by current GMP and the company Quality Policies and site SOPs
- Ability to accurately complete required documentation
- Excellent organization, detail oriented and accurate
- Knowledge of MS Office (Word, Excel, Outlook)
Preferred Experience, Skills & Abilities:
- Ability to multi-task and prioritize work assignments with little supervision.
- Experience with Quality System investigations and other concepts (Deviation, OOS, CAPA, Change Control, Audits, etc.).
- Experience with MasterControl/Trackwise/LIMS/MODA etc is a plus
- Experience in developing cGMP training materials is preferred
- Must have working knowledge of FDA (21CFR 210, 211 & 820) and EU regulatory requirements
- Previous experience implementing or administration of an eQMS software system is necessary
Working Conditions & Physical Requirements:
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 regularly required to:
- Must be willing to work flexible hours
- Experience prolonged standing, some bending, stooping, and stretching
- Ability to sit for long periods to work on a computer
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required
- Attendance is mandatory
- BA/BS in life sciences, information technology, or relevant field with 2+ years of relevant experience, preferably in an FDA regulated environment