Quality Associate II/III (2nd Shift)

Company Name: Grifols

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.

Schedule:

Second Shift

Job Description

The Quality Associate II/III provides routine technical support for various tasks, assignments, and projects in the QA Fractionation business unit. This includes 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. Other tasks performed by the Quality Associate II/III may also include those associated with release and shipment of Contract Fractionation batches and Quarantine of intermediates.

Responsibilities Include

• Collects, reviews and may analyze data
• Makes decisions within a well-defined area that may influence the department goals
• Coordinates work assignments
• Addresses and resolves problems according to written procedures (eg. SOP) or practice
• Communicates effectively and promptly
• 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 to generate department reports
• Communicate effectively at all levels of the organization, supporting department objectives and management decisions
• Perform roles and/or tasks associated with one or more Quality System function such as Batch Release, SAP Quality Module, Documentation, Change Control, Discrepancy Management, Quarantine, and Annual Product Reviews
• May also provide Quality support 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

Successful candidates should have excellent communication skills (written and verbal), attention to detail, and the ability to be flexible and adapt to sudden changes in priorities and deadlines. He/she must have the ability to multi-task, work well under time constraints, and demonstrate consistent application of technical knowledge. He/she should also have basic knowledge/understanding of domestic (i.e. Food and Drug Administration) and applicable foreign regulatory agency requirements/guidelines.

Preference will be given to candidates with knowledge of plasma release, pooling and/or fractionation processes and/or experience reviewing and approving others’ work such as batch records, test data, reports etc.

Required Education

Quality Associate II

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.

Quality Associate III

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.

Third Party Agency And Recruiter Notice

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

Equal Employment Opportunity

Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants in a manner consistent with the requirements of applicable state and local laws.

Location

NORTH AMERICA : USA : NC-Clayton:USNC0002 - Clayton

Learn more about Grifols