Key skills
Communication
About this role
Role Overview
- Responsible for the daily data entry and managing of change control documentation in the Access Change Request Database
- Responsible for review and workflow management of change control records in electronic Quality Management System (Veeva)
- Responsible for review of change control and associated requirements documentation for accuracy, completeness, compliance with cGMPs and applicable standards
- Will generate reports on a scheduled basis for the status of all open/closed change requests and issuance of documents.
- Responsible for follow-up on status/open requirements for change control
- Responsible for sending notification to other Grifols sites as required by change control
- Responsible for issuance of tag-outs for equipment/facilities as required by change control
- Generate reports and data for Key Performance Indicator reporting
- Responsible for processing and maintenance of documents in Document Management System managing workflows of review, approval, issuance, and effective.
- Assist as needed for projects related to document management systems and change control
- Familiar with Microsoft Excel, eQMS and Access to utilize for tracking, trending, and data entry.
- Communicate effectively with multiple departments in order to provide customer service.
Requirements
- Bachelor's degree and a minimum of 2 years of related experience; or an advanced degree without experience; or equivalent work experience.
- Related cGMP industry experience is desirable
- Experience working with eQMS highly desirable
- Ability to keep neat, accurate and complete records and logs.
- Must be proactive, results oriented, with a strong attention to detail.
- Self-starter with good work ethic and ability to work independently with minimum supervision and use good judgment, or as a contributing member of a team.
- Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever changing, fast paced critical work environment.
- Strong organizational, analytical, troubleshooting and problem-solving skills.
- Ability to analyze details and perform structured decision-making on a daily basis.
- Excellent verbal and written communication.
- Must be able to read, write, and speak English.
- Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner.
- Good computer skills with basic knowledge of Microsoft programs, particularly Outlook, Word, Excel, Access, etc.
Benefits
- Medical
- Dental
- Vision
- life insurance
- PTO
- paid holidays
- up to 5% 401(K) match
- tuition reimbursement