QA Coordinator

Grifols•Los Angeles, CA

About The Position

The QA Coordinator is responsible for workflow management and review of change-control documentation and documents in the document management system. The position issues production work and support orders and logs, tracks pending tasks in the electronic quality management system and follows up to ensure completion, and performs daily database operations, including data entry, report preparation, and distribution. The role works with change-control records and associated documentation to ensure accuracy, completeness, and compliance with cGMPs and applicable standards. It also supports document-management and change-control projects as needed and communicates with multiple departments to provide customer service. Work takes place in an office and a laboratory/manufacturing environment or warehouse. The estimated California pay scale is $79,318–$99,147, with eligibility to participate in up to 5% of the company bonus pool. Grifols offers benefits including medical, dental, vision, life insurance, PTO, paid holidays, up to 5% 401(k) match, and tuition reimbursement. The company also describes opportunities for professional growth and career progression.

Requirements

Bachelor's degree and at least 2 years of related experience; or an advanced degree without experience; or equivalent work experience.
Ability to maintain neat, accurate, and complete records and logs.
Proactive, results-oriented approach and strong attention to detail.
Self-starter with a good work ethic; able to work independently with minimum supervision, use 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 skills; ability to read, write, and speak English.
Strong interpersonal skills and ability to interact professionally with personnel at all levels.
Good computer skills, including basic knowledge of Microsoft Outlook, Word, Excel, and Access.
Ability to communicate complex information and ideas clearly and understand spoken and written information.
Ability to follow written or oral instructions and procedures.
Ability to work around biological fluids with potential exposure to infectious organisms, occasional extreme cold below 32 degrees in production areas, and electrical office and laboratory equipment.
Ability to use required personal protective equipment, including protective eyewear, garments, and gloves.
Ability to sit or stand for 2–4 hours per day; frequent hand and finger movement and precise coordinated movements to grasp and manipulate objects.
Ability to lift and carry light to moderate objects up to 35 pounds; occasionally walk, bend, twist the neck and waist, and reach above or below shoulder height; frequent foot movements.
Color perception and discrimination, and near vision correctable in one eye to 20/30 and the other eye to 20/100.

Nice To Haves

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

Responsibilities

Perform daily data entry and manage change-control documentation in the Access Change Request Database.
Review and manage workflows for change-control records in the electronic Quality Management System (Veeva).
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 requests 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, managing review, approval, issuance, and effectiveness workflows.
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.