Sr. Quality Associate I/II

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.

Hours: Day Shift - Monday through Friday: 8:00 am to 5:00 pm

Sr. Quality Associate I / II / Principal, Quality Assurance:

The Senior Quality Associate I/II/Principal will be assigned duties and responsibilities within the General Computer Systems Group in the Quality Assurance area, with specific duties pertaining to the Laboratory Execution System (LES) project for the creation and maintenance of SAP Quality Master Data for production and raw material inspection plans, master inspection characteristics, sample drawing procedures and plans, reportable characteristics, and maintaining Engineering Change Management in SAP. The incumbent must have extensive SAP QM inspection plan experience and must be an established and technically competent professional who independently develops and implements solutions to a variety of quality related objectives. LES/LIMs experince/knowledge is preferred. 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, developing solutions for defined problems. The employee may be responsible for training other employees and is a fully qualified professional who requires minimal supervision. Extensive experience with SAP QM and the overall quality and manufacturing process from pooling to packaged final container is preferred.

The Senior Quality Associate II- Additional responsibilities in addition to the Associate I will also include: 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.

The Principal Quality Associate, may be assigned additional duties and responsibilities within Quality Assurance. Specific duties will depend on the assignment and may include; SAP troubleshooting and issue resolution for various business groups including QA, QC, Planning, Manufaturing, and Finance. The incumbent is a professional with high technical competency who leads project teams. Can make quality decisions for the team. The employee influences the direction of complex projects and communicates with all levels of employees. Can identify continuous improvement opportunities and drive the change and assess impact to other areas of the business. 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. Serves as delegate to the manager.

Responsibilities Include:

Sr. Quality Associate I-

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  Consults with management to develop and implement solutions for achieving quality related objectives.

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  Uses expertise to make independent decisions within defined areas of responsibility.

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  Participates on multi-disciplined project teams.

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  Collects and analyzes data

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  Demonstrated ability to make sound quality decisions with moderate guidance

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  Demonstrates high levels of values and integrity.

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  Follows cGMP and department safety practices.

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  Other duties as assigned or as specified in the "Additional Responsibilities" section below may apply.

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Sr. Quality Associate II-

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

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

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

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  May mentor employees.

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

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  Demonstrates high levels of values and integrity.

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  Follows cGMP and department safety practices.

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  Demonstrated ability to make sound quality decisions with minimal guidance

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  Other duties as assigned or as specified in the "Additional Responsibilities" section below may apply.

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

Principal Quality Associate-

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

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  Responsible for development, maintenance and vitality of essential Grifols technologies.

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

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

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  May mentor employees.

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

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  Demonstrates high levels of values and integrity

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  Can easily multi-task, prioritize and adapt to changing business needs

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  Preparation/review/approval of regulatory documents

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  Demonstrated ability to independently make sound quality decisions

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  Demonstrated ability to influence decisions makers in other departments

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  Review and approval of SAP validations

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  Other duties as assigned or as specified in the "Additional Responsibilities" section below may apply.

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In addition to the duties described above the Principle Quality Associate, 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,

SAP QM support for Inspection Lot, Quarantine, Batch Release issues, and Production Order Issues related to SAP QM. Provide SAP Inspection plan support for Annual Product Reviews as well as provide Quality input for Validation projects, clinical studies, stability studies, and Regulatory submissions. Responsible for representing Quality manager at business unit meetings, and project meetings. Excellent communication skills (written and verbal). Demonstrated use of domestic (i.e. Food and Drug Administration) and applicable foreign regulatory agency requirements/guidelines. Be able to work independently.

Requirements:

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 combination of education and experience. Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements.

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 combination of education and experience. Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements.

Principal Quality Associate- BA/BS degree preferably in a STEM (Science, Technology, Engineering, and Mathematics) discipline with minimum of 8 years relevant experience. A minimum of a BA/BS is required. Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements.

Work is performed in an office environment. Able to communicate complex 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. Performs tasks by following a set of written or oral instructions/procedures.

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; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.

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Req ID:

Type: Regular Full-Time

Job Category: Quality