Sr. Quality Associate I, Quality Compliance

GRIFOLS, S.A.•NC-Clayton, CA

8d•Onsite

About The Position

The Senior Quality Associate I is assigned duties and responsibilities within the Quality Compliance Department. Specific duties will depend on the assignment and may include any of the following: review of manufacturing or testing reports, coordination of Batch Production Records/Standard Operating Procedures/Electronic Batch Records, auditing, data analysis, etc. The incumbent is an established and technically competent professional who independently develops and implements solutions to a variety of quality related objectives. He/she may lead teams or projects of varying scope and is often called upon by peers for his/her expertise or guidance. Demonstrates consistent application of technical knowledge and expertise, executes assignments of medium complexity, developing solutions for defined problems. The employee may be responsible for training other employees and is a fully qualified professional who requires minimal supervision.

Requirements

BA/BS - preferably in a STEM (science, technology, engineering, or mathematics) curriculum and 5 yrs of relevant experience or an equivalent combination of education and experience.
Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.
Basic knowledge and understanding of domestic (e.g., US Food and Drug Administration CFR) and applicable foreign regulatory agency requirements and guidelines.

Nice To Haves

Quality Control experience and/or knowledge of QC relevant documents.
Qualified Author

Responsibilities

Maintain Qualified Author status to author and revise documents in accordance with governing SOPs.
Coordinate the development, maintenance, review, routing for dispositions, periodic reviews, publishing, and historical file management in the Document Management System (DMS) and Aizon Electronic Batch Record system of site controlled documents such as Batch Production Records (BPRs), Standard Operating Procedures (SOPs), and Electronic Batch Records (EBRs).
Review and evaluate documentation assuring compliance with cGMPs, cGDocPs, BLAs, and other regulatory requirements as well as Grifols Therapeutics site established quality standards (e.g., GT Style Guide, defined format requirements, grammar, punctuation, and spelling).
Coordinate the review, upload, route for reviews, publishing, periodic reviews, and maintain the historical files for Risk Assessments, Manufacturing Methods, Project Plans, etc. in the Document Management System.
Execute changes (e.g., format, content, entry field settings, calculations, etc.) to electronic batch record Master Recipes in Aizon.
Process document periodic reviews and distribute notifications to reviewers allowing sufficient time for evaluation and processing prior to the due date to comply with the Grifols Quality Metric.
Conduct instructor-lead training classes (e.g., Word Processing) for author qualifications.
Author, revise, review, coordinate, route for disposition, and/or approve Change Control Requests, Incident Tracking System entries, and/or investigation reports.
Represent Quality Document Management in discussions and meetings with other business groups providing input, feedback, and direction for the creation, revision, and/or maintenance of documents to support operational and strategic goals (e.g., complying with CAPA Due Dates, project target dates).
Collaborate with Manufacturing, Quality Assurance, Quality Control, Validation, and other site-wide departments on projects, incident investigations, CAPAs, change controls, improvements of Quality Management Systems, etc.
Update Doc Profile and the Document Management System as documents are processed. Generate and review reports from each to ensure alignment and post the applicable reports to Cosmos.
Assist in the facilitation and hosting of site regulatory inspections and customer audits.
Consults with management to develop and implement solutions for achieving quality related objectives.
Assists in the effective deployment of divisional or departmental technical resources in pursuit of annual goals.
Uses expertise to make independent decisions within defined areas of responsibility.
Leads or participates on multi-disciplined project teams. Also advances technical project proposals to senior management, following through to successful completion.
Collects and analyzes data to generate overview reports as needed.
Has excellent communication skills (written and verbal) with basic knowledge and understanding of domestic (e.g., US Food and Drug Administration CFR) and applicable foreign regulatory agency requirements and guidelines.
Other duties as assigned.
Participate in internal and supplier compliance audits.
Review and analyze data, prepare and review reports.
Participate in failure investigations.