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.

Supervisor II/III/Sr - Quality Assurance:

Summary:

The Supervisor Quality Assurance II, III, Senior Supervisor is responsible for supervising or overseeing a group of employees or a Quality Assurance system, program, project, etc. Participates in employee relations matters and is responsible for performance management in area of responsibility. May facilitate technical and non-technical training. Responsibilities may also 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 meetings. The employee may be responsible for training or supervising other employees and is a fully qualified professional who requires minimal supervision.

Primary Responsibilities include, but are not limited to the following:

• Additional responsibilities will include preparation of release protocols and necessary certification for new market registration and license renewal.

• Support changing market requirements.

• Maintenance of release certificates of analysis, preparation of periodic RA reports, tracking batch release status including accepted, rejected, reprocessed, and reworked batches. Managing document revisions in support of change controls, projects, continuous improvement initiatives, etc.

• Support IT projects related to batch release. Assist with tracking media fills and personnel training within the department.

• Assist with maintenance of release SAP master data, assess deviation market impact in segmentation, support packaging operations, and upkeep of metrics.

• Experience in related areas such as Manufacturing, Regulatory Affairs, SAP QM, change controls, deviations, validation systems, computer systems, and audit trails, or other related quality systems is highly preferable.

Education and Requirements :

Candidates for the Supervisor II-QA : BS/BA preferably in a STEM (Science, Technology, Engineering, and Mathematics) discipline with minimum of 5 years relevant experience, or equivalent combination of education and experience.

Candidates for the Supervisor III-QA : BS/BA degree preferably in STEM (Science, Technology, Engineering, and Mathematics) discipline with a minimum of 6 years relevant experience, or equivalent combination of education and experience.

Candidates for the Sr. Supervisor-QA : BS/BA in preferably in STEM (Science, Technology, Engineering, and Mathematics) discipline with a minimum of 8 years relevant experience. A minimum of a BA/BS is required.

Knowledge, Skills, and Abilities

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

Occupational Demands:

Work is performed in an office and/or a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Exposure to extreme cold below 32*, miscellaneous production chemicals, moving machinery and production equipment. Exposure to high levels of noise on production floor. Personal protective equipment required such as protective eyewear, garments, and gloves. Frequently sits for 4-6 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks. Often performs duties standing. Frequently bends and twists neck and waist. Light to moderate lifting and carrying objects with a maximum lift of 35lbs. Frequently drives to other facilities. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Frequently interacts with others, relates sensitive information to diverse groups.

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 (https://www.grifols.com/en/what-we-do)

Req ID: 515534

Type: Regular Full-Time

Job Category: Quality