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Grifols Shared Services North America, Inc Quality Associate II/III - QA NFF in Clayton, North Carolina

For more than 75 years, Grifols has worked to improve the health and well-being of people around the world. We are a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to deliver expert medical care.

Requisition 83124 Job Posting

Title: Quality Associate II/III – QA NFF

Note this position is for 2 nd shift 1:00pm – 9:30pm

Job Description

The Quality Associate II/III provides routine technical support for various tasks, assignments, and projects in the QA NFF business unit, including pre-pooling release of plasma pool shipments, assessment of plasma post donation & lookback alerts, preparation of pool sample shipments to the PEI, and manufacturing record review for Pooling through Fractionation Batch Release to support department cycle time goals. He/she may be responsible for coordinating work assignments and training of other employees.

Responsibilities include:

  • Collects, reviews and may analyze data and generate department reports

  • Makes decisions within a well-defined area that may influence the department goals

  • Addresses and resolves problems according to written procedures (eg. SOP) or practice

  • Communicates effectively and promptly, supporting department objectives and management decisions

  • Demonstrates high levels of values and integrity

  • Follows cGMP and department safety practices

  • May train other employees

Additional responsibilities may also include:

  • Execute assignments of medium complexity

  • Develop solutions to defined problems

  • Collect, review and analyze data

  • Perform roles (such as author, reviewer, approver, administrator or coordinator) in Quality Systems such as Change Control, Discrepancy Management, Quarantine, Batch Release, SAP, SAP Quality Module, Documentation, and Annual Product Reviews

  • May also provide Quality input for validation, capital projects, ETPs, Regulatory submissions, or other studies

Some tasks will be performed in a gowned, classified area including in +5°C or colder environments.

Knowledge, Skills, and Abilities

Excellent communication skills (written and verbal). Has basic knowledge/understanding of domestic (i.e. Food and Drug Administration) and applicable foreign regulatory agency requirements/guidelines.

Requirements

Candidates for the Quality Associate II must have a BS/BA degree preferably in STEM (Science, Technology, Engineering, and Mathematics) discipline with a minimum of 2 years relevant experience, or equivalent combination of education and experience.

Candidates for the Quality Associate III must have a BS/BA degree preferably in STEM (Science, Technology, Engineering, and Mathematics) discipline with a minimum of 3 years relevant experience, or equivalent combination of education and experience.

Relevant experience should include:

  • Performing roles (such as author, reviewer, coordinator and/or approver) for one or more Quality System function such as Change Control, Discrepancy Management, Quarantine, Batch Release, SAP, SAP Quality Module, Documentation, and Annual Product Reviews, including review and/or approval of others’ work, and/or data analysis and review.

  • Demonstrate consistent application of their technical knowledge and expertise and attention to detail

  • Ability to be flexible and adapt to sudden changes in priorities and deadlines, multi-task, and work well under time constraints.

Location: [[mfield6]] : [[cust_building]]

Learn more about Grifols at http://www.grifols.com/es/web/international/home

Req ID: 83124

Type: Regular Full-Time

Job Category: Manufacturing

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