What are the responsibilities and job description for the Sr. Quality Associate II/Principal - QA position at Lensa?
Lensa is the leading career site for job seekers at every stage of their career. Our client, Grifols Shared Services North America, Inc, is seeking professionals in Clayton, NC. Apply via Lensa today!
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 incumbent will be assigned duties and responsibilities within Quality Assurance to support the QA Fraction II Business Unit which provides Quality oversight for the following GT products: IGIV-C, IGSC, IGIM-C, IGCP. In this role the incumbent will interface with plant manufacturing and support groups to execute site quality systems. Specific duties may include serving as author, reviewer, administrator or coordinator for quality systems such as Change Control, Discrepancy Management (including deviations, Product Technical Complaints and CAPAs), Quarantine, Documentation, and Annual Product Reviews as well as providing Quality input for Validation projects, Regulatory submissions and audits. The incumbent will be responsible for representing Quality at project meetings. The incumbent is an established and technically competent professional who develops and provides solutions/ is able to influence the direction of project/quality related objectives.
The incumbent may participate on teams or projects of varying scope and is often called upon by peers for their expertise or guidance/ is recognized as an authority in multiple areas. The incumbent demonstrates consistent application of technical knowledge and expertise, executes assignments of medium to complex nature, developing solutions for defined technical problems. The employee may be responsible for training other employees and is a fully qualified professional who requires minimal supervision.
The incumbent must have a strong knowledge of cGMPs, the ability to perform independently, and the ability to solve moderate technical problems. Knowledge of assays and processes is recommended. A proactive philosophy, attention to detail, and good human interaction skills are essential and must have been demonstrated in previous work. The incumbent should be able to prepare reports/presentations and be able to effectively communicate information to varying levels of management.
The incumbent should be able to actively participate on teams of varying complexity. The incumbent must be a professional with moderate to high technical competency. Incumbent must have good to excellent judgement, and investigative, analytical, and organizational skills. Desired computer skills include Excel, Word and SAP. Experience in different aspects of pharmaceutical business is a plus.
Requirements
Sr. QA 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.
Sr. QA 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
Principal: BS/BA degree preferably in a STEM (Science, Technology, Engineering, and Mathematics) discipline with minimum of 8 years relevant experience. A minimum of a BS/BA 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 (https://www.grifols.com/en/what-we-do)
Req ID: 525543
Type: Regular Full-Time
Job Category: Quality
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 incumbent will be assigned duties and responsibilities within Quality Assurance to support the QA Fraction II Business Unit which provides Quality oversight for the following GT products: IGIV-C, IGSC, IGIM-C, IGCP. In this role the incumbent will interface with plant manufacturing and support groups to execute site quality systems. Specific duties may include serving as author, reviewer, administrator or coordinator for quality systems such as Change Control, Discrepancy Management (including deviations, Product Technical Complaints and CAPAs), Quarantine, Documentation, and Annual Product Reviews as well as providing Quality input for Validation projects, Regulatory submissions and audits. The incumbent will be responsible for representing Quality at project meetings. The incumbent is an established and technically competent professional who develops and provides solutions/ is able to influence the direction of project/quality related objectives.
The incumbent may participate on teams or projects of varying scope and is often called upon by peers for their expertise or guidance/ is recognized as an authority in multiple areas. The incumbent demonstrates consistent application of technical knowledge and expertise, executes assignments of medium to complex nature, developing solutions for defined technical problems. The employee may be responsible for training other employees and is a fully qualified professional who requires minimal supervision.
The incumbent must have a strong knowledge of cGMPs, the ability to perform independently, and the ability to solve moderate technical problems. Knowledge of assays and processes is recommended. A proactive philosophy, attention to detail, and good human interaction skills are essential and must have been demonstrated in previous work. The incumbent should be able to prepare reports/presentations and be able to effectively communicate information to varying levels of management.
The incumbent should be able to actively participate on teams of varying complexity. The incumbent must be a professional with moderate to high technical competency. Incumbent must have good to excellent judgement, and investigative, analytical, and organizational skills. Desired computer skills include Excel, Word and SAP. Experience in different aspects of pharmaceutical business is a plus.
Requirements
Sr. QA 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.
Sr. QA 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
Principal: BS/BA degree preferably in a STEM (Science, Technology, Engineering, and Mathematics) discipline with minimum of 8 years relevant experience. A minimum of a BS/BA 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 (https://www.grifols.com/en/what-we-do)
Req ID: 525543
Type: Regular Full-Time
Job Category: Quality
