Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.

The Sr. Quality Associate I/II, Principal Quality Associate will be assigned duties and responsibilities within the Quality Compliance/Supplier Quality Department. Specific duties will depend on the assignment and may include any of the following: lead/perform extractable/leachable assessments, coordination of the commodity/service qualification process (including material clearance testing); coordination/evaluation for supplier change notifications; review of manufacturing or testing reports; authoring/revising raw material specifications, standard operating procedures, risk assessments and quality agreements; and initiation of change control requests. Other duties may include performing raw material discrepancy/CAPA management and regulatory inspection/customer audit hosting activities.

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, and develops solutions for defined problems. The employee may be responsible for training other employees and is a fully qualified professional who requires minimal supervision.

In-depth knowledge of SAP, Microsoft Word, and Excel are required.

Knowledge, Skills, and Abilities:

• Excellent communication skills (written and verbal) and attention to detail. This position regularly interacts with members of management within the GT Clayton site, other Grifols Biopharma sites, suppliers/customers, and/or regulatory agencies.

• Excellent organizational skills and the ability to follow up on matters consistently and diligently until timely resolution is achieved.

• Knowledge/ understanding of domestic (e.g., US Food and Drug Administration) and applicable foreign regulatory agency requirements/guidelines.

• Technical report writing skills with the ability to produce high quality documentation appropriate for its intended audience.

• Proficiency in identifying appropriate test methodologies as defined in the applicable pharmacopoeia (USP, EP, or JP).

• Ability to make sound, independent quality decisions with moderate to minimal guidance within defined areas of responsibility and demonstrates the ability to influence technical decisions of complex projects and/or business units.

• Follows cGMP and departmental safety practices.

• Collects/ analyzes large volumes of data and is able to make sound recommendations based on analysis.

• Demonstrates high levels of values and integrity.

• Ability to easily multi-task, prioritize and adapt to changing business needs, as well as recognize opportunities for continuous improvement and to lead/drive necessary changes.

Required Education:

Sr. Quality Associate I, Quality Compliance: BS/BA degree preferably in a STEM (Science, Technology, Engineering, and Mathematics) discipline with minimum of 5 years relevant experience, or equivalent combination of education and experience.

Sr. Quality Associate II, Quality Compliance: BS/BA degree preferably in a STEM (Science, Technology, Engineering, and Mathematics) discipline with minimum of 6 years relevant experience, or equivalent combination of education and experience.

Principal Quality Associate, Quality Compliance: BS/BA degree preferably in a STEM (Science, Technology, Engineering, and Mathematics) discipline with minimum of 8 years relevant experience. A minimum of a BA/BS degree is required.

Req ID: 501532

Type: Regular Full-Time

Job Category: Quality