Quality Associate 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. Quality Associate II / Quality Associate III, QA QA FC Release Certifications Review and prepare Import Documentation required by ICON Review product Certificate Analysis to ensure that the applicable specification is applied Review specifications associated with each market Review Import Permits, Reallocations and Quality Agreements to ensure certificates are prepared accordingly Consults with Regulatory Affairs on required documents needed for renewals and submissions, develop protocols and other supplemental documents to support these submissions. Summary The Quality Associate II/II provides routine technical support for various tasks (i.e. documentation, training, compliance, product release, scheduling, etc.), assignments, projects, etc. He/she may be responsible for coordinating work assignments and training other employees. Execute assignments of medium complexity and develop solutions to defined problems for Quality Assurance. Fully qualified professional who requires minimal supervision. Primary responsibility of this position is final container product releasealong with other responsibilities listed below. The candidate will be expected to perform batch related activities and meet cycle time releases. He/she must be aware that priorities may change frequently. Primary responsibilities for QA II role Collects, reviews, and may analyze data. Makes decisions independently, but within a well-defined area. Addresses and resolves problems according to written procedure (i.e. SOP, etc.) or practice. May supervise or train employees. Communicate effectively and promptly at all levels of the organization, supporting department objectives and management decisions. Demonstrates high levels of value and integrity. Follows cGMP and department safety practices. Additional Responsibilities In addition to the duties described above in the Quality Associate II, Quality Assurance may also perform the following duties based upon the business unit to which he/she is assigned: Responsibilities may include roles (such as author, reviewer) in quality systems such as Change Control, Discrepancy Management, Quarantine, Batch Release, SAP, SAP Quality Module, Documentation, as well as provide Quality input for Validation projects, capital engineering projects, clinical studies, stability studies, ETPs, and Regulatory submissions. QA III Primary responsibilities for QA III role Develops alternative solutions to problems, handles complex problems independently. Demonstrates strong technical expertise and ability to adapt to changing circumstances. Collects, reviews, and may analyze data. May supervise or train employees. Makes decisions with designated assignments that influence the goals of the department. Communicates effectively and promptly at all levels of the organization, supporting department objectives and management decisions. Demonstrates high levels of value and integrity. Follows cGMP and department safety practices. Additional Responsibilities In addition to the duties described above the Quality Associate III, Quality Assurance may also perform the following duties based upon the business unit to which he/she is assigned: Responsibilities may include roles (such as author, reviewer, 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. Experience, Skills, and Knowledge QA work experience, experience reviewing BPRs. Possess excellent organizational skills, communication skills, detail oriented and is very efficient. Education and Experience Requirements QA II: BS/BA degree preferably in a STEM (Science, Technology, Engineering, or Mathematics) and a minimum of 2 years of related experience, or equivalent combination of education and experience. QA III: BS/BA preferably in a STEM degree with minimum of 3 years relevant experience, or equivalent combination of education and experience. Location: NORTH AMERICA : USA : NC-Clayton: [[cust_building]] 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. Learn more about Grifols #J-18808-Ljbffr