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Grifols Shared Services North America, Inc Sr. Quality Associate II in Clayton, North Carolina

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.

Summary:

The Senior Quality Associate I/II, Quality Assurance may be assigned duties and responsibilities within Quality Assurance. Specific duties will depend on the assignment and may include; review of manufacturing or testing records, preparation or review of failure investigations, sampling/testing/data analysis, auditing, data analysis for stability, etc. The incumbent is a professional with high technical competency who leads project or discipline teams. The employee influences the direction of complex projects and communicates with all levels of employees. The incumbent is recognized as an authority in multiple areas and provides leadership and guidance to others. The employee may be responsible for training other employees and is a fully qualified professional who requires minimal supervision.

Primary responsibilities for role:

  • Use expertise to advise and influence the technical decisions of business units.

  • Interacts regularly with members of management and as needed with regulatory officials.

  • Lead multi-disciplined project teams with highly technical objectives. Communicates project proposals to senior management and follows project through to successful completion.

  • May mentor employees.

  • Prepares, reviews, and in some cases approves SOP revisions, Change Control Requests. Incident Tracking System entries and investigation reports.

  • Demonstrates high levels of values and Integrity.

  • Follows cGMP and department safety practices.

  • Demonstrated ability to make sound quality decisions with minimal guidance.

  • Other duties as assigned.

Additional Responsabilities:

In addition to the duties described above the Sr. Quality Associate I/II, Quality Assurance may also perform the following duties based upon the business unit to which he/she is assigned:

Responsibilities may include advanced roles (such as author, reviewer, approver, administrator or coordinator) in all quality systems such as Change Control, Discrepancy Management, Quarantine, Batch Release, SAP, SAP Quality Module, Documentation, and Annual Product Reviews as well as provide Quality input for Validation projects, capital engineering projects, clinical studies, stability studies, ETPs, and Regulatory submissions. Responsible for representing Quality at business unit meetings, and project meetings.

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.

Education and Experience:

Sr. Quality Associate I:

  • BS/BA degree preferably in a STEM (Science, Technology, Engineering, and Mathematics)discipline with minimum of 5 years relevant experience, or equivalent.

Sr. Quality Associate II:

  • BS/BA degree preferably in STEM( Science, Technology, Engineering, and Mathematics) discipline with minimum of 6 years relevant experience, or equivalent.

Equivalency:

Depending on the area of assignment, directly related or a combination of directly related education and experience and/or competencies may be considerered in place of the stated requirements. Example: If a job level requires a Bachelors'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.

EEO Minorities/Females/Disability/Veterans

Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

*This job description is accurate at the date of publication and may change over time. It is not intended as an exhaustive description of the job. Other duties may be assigned and qualifications required may change.

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, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

Learn more about Grifols (https://www.grifols.com/en/what-we-do)

Req ID: 512523

Type: Regular Full-Time

Job Category: Quality

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