QA Coordinator

GRIFOLS, S.A.•CA-Los Angeles, CA

4d•$79,318 - $99,147•Onsite

About The Position

The QA Coordinator manages workflow and reviews change control documentation and documents in the Document Management System. The role issues production work and support orders and logs, tracks pending tasks in the electronic quality management system, coordinates follow-up for completion, and performs daily database operations such as data entry, report preparation, and distribution. The position handles change control documentation and records in the Access Change Request Database and Veeva eQMS; reviews documentation for accuracy, completeness, and compliance with cGMPs and applicable standards; and processes document workflows for review, approval, issuance, and effectiveness. It generates status and KPI reports, follows up on open requirements, notifies other Grifols sites as required, and issues equipment or facility tag-outs when required. The coordinator may also assist with projects related to document management systems and change control and communicates with multiple departments to provide customer service. Work takes place in an office and a laboratory/manufacturing environment or warehouse. The role involves potential exposure to biological fluids and infectious organisms, occasional extreme cold below 32 degrees in production areas, and electrical office and laboratory equipment. Personal protective equipment such as protective eyewear, garments, and gloves is required. Physical activities include sitting or standing, frequent hand and foot movements, occasional walking, bending, twisting, and reaching, and light to moderate lifting and carrying up to 35 pounds.

Requirements

Bachelor's degree and at least 2 years of related experience; or an advanced degree without experience; or equivalent work experience.
Ability to keep neat, accurate, and complete records and logs.
Proactive, results-oriented approach and strong attention to detail.
Self-starter with a good work ethic and ability to work independently with minimal supervision, exercise good judgment, and contribute as a team member.
Ability to manage multiple projects simultaneously, meet deadlines, and work in a changing, fast-paced, critical 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; ability to read, write, and speak English.
Strong interpersonal skills and ability to interact professionally with personnel at all levels.
Good computer skills and basic knowledge of Microsoft programs, particularly Outlook, Word, Excel, and Access.

Nice To Haves

Related cGMP industry experience is desirable.
Experience working with eQMS is highly desirable.

Responsibilities

Enter data daily and manage change control documentation in the Access Change Request Database.
Review and manage workflows for change control records in the Veeva electronic Quality Management System.
Review change control and associated requirements documentation for accuracy, completeness, and compliance with cGMPs and applicable standards.
Generate scheduled reports on the status of open and closed change requests and document issuance.
Follow up on the status of change control and open requirements.
Send notifications to other Grifols sites as required by change control.
Issue equipment and facility tag-outs as required by change control.
Generate reports and data for Key Performance Indicator reporting.
Process and maintain documents in the Document Management System, including workflows for review, approval, issuance, and effectiveness.
Assist with projects related to document management systems and change control as needed.
Use Microsoft Excel, eQMS, and Access for tracking, trending, and data entry.
Communicate effectively with multiple departments to provide customer service.