QA Coordinator

GRIFOLS, S.A.

2d•$77,000 - $90,000

About The Position

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. This position will be responsible for workflow management and review of change control documentation and documents in Document management system, issuance of production work/support orders and logs, tracking pending tasks in electronic quality management system and coordinate/follow up for completion and performing daily database operations, including data entry, report preparation, and distribution.

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
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 judgent, 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.

Nice To Haves

Experience working with eQMS highly desirable

Responsibilities

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.