Sr. Quality Associate I / Sr. Quality Associate II / Principal Quality Associate, Quality Compliance

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.

The Sr. Quality Associate I / Sr. Quality Associate II / Principal Quality Associate provides routine technical support for various assignments, tasks, projects, etc. within the Quality Compliance/Supplier Quality Department.

Primary Responsibilities for this Role:

• Coordinates and leads the timely completion of extractable/leachable risk assessments for product contact materials.

• Selects the appropriate test methods based on applicable compendial (e.g., USP, EP, or JP) and internal requirements to support material qualification and coordinates samples with both internal and external testing laboratories.

• Authors technical reports summarizing and explaining the results of laboratory studies from different analytical techniques such as LC/MS, GC/MS, UV/VIS, ICP/OES, FTIR, TOC, etc.

• Authors standard operating procedures, supplier/material related risk assessments, commodity evaluation requests/reports, and change controls.

• Participates in the supplier change notification process.

• Maintains and updates material clearance documentation, database records, and reports.

• Assists with the coordination of commodity evaluation requests which includes obtaining and evaluating regulatory documentation from suppliers, working with stakeholders to complete internal requirements, and ensuring completion of required analytical evaluations.

Additional Responsibilities:

• Partners with stakeholders to identify and implement continuous improvement solutions with demonstrated/measured business results

• Participates in cross functional teams providing support as needed

• Leads teams or projects of varying scope and medium complexity

• Supports regulatory inspection/customer audit hosting activities

• Provides support to other functions within the Quality Compliance group

• Provides guidance and training for other employees

Knowledge, Skills, and Abilities:

• Knowledge of domestic and foreign regulatory agency requirements as well as relevant regulatory guidance on analytical methods for extractable and leachable studies. Communicates effectively and promptly, supporting department objectives and management decisions

• Investigation skills with nonconformances including root cause analysis and corrective/preventive actions

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

• Demonstrated ability to consistently apply technical knowledge in making sound quality decisions with minimal guidance

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

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

• Ability to think critically/strategically and act proactively

• Uses expertise to make independent decisions within defined areas of responsibility and demonstrates the ability to influence technical decisions of complex projects and/or business units

• Embraces a behavior of employee involvement/partnering and commitment to doing the job right the first time

• Collects, reviews, and may analyze large volumes of data and is able to make sound recommendations based on analysis

• Demonstrates high levels of values and integrity

• Follows cGMP and departmental safety practices

• Knowledge and experience using Microsoft Office applications required

• Knowledge and experience using SAP preferred

This job description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Manager may assign other duties as needed.

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.

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.

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.

Learn more about Grifols (~~~)

Req ID: 515794

Type: Regular Full-Time

Job Category: Quality