Quality Associate II/III (QA Fractionation Batch-Release)

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.Shift: First ShiftSummary:The Quality Associate II/III provides routine technical support for various tasks, assignments, and projects in the QA Fractionation business unit. This includes release and shipment of Contract Fractionation batches, pre-pooling release of plasma pool shipments, assessment of plasma post donation & lookback alerts, preparation of pool sample shipments to the PEI, and manufacturing record review for Pooling through Fractionation Batch Release to support department cycle time goals. Other tasks performed by the Quality Associate II/III may also include those associated with Quarantine of intermediates.Responsibilities include:Collects, reviews and may analyze dataMakes decisions within a well-defined area that may influence the department goalsCoordinates work assignmentsAddresses and resolves problems according to written procedures (eg. SOP) or practiceCommunicates effectively and promptlyDemonstrates high levels of values and integrityFollows cGMP and department safety practicesMay train other employeesAdditional responsibilities may also include:Execute assignments of medium complexityDevelop solutions to defined problemsCollect, review and analyze data to generate department reportsCommunicate effectively at all levels of the organization, supporting department objectives and management decisionsPerform roles and/or tasks associated with one or more Quality System function such as Batch Release, SAP Quality Module, Documentation, Change Control, Discrepancy Management, Quarantine, and Annual Product ReviewsMay also provide Quality support for validation, capital projects, ETPs, Regulatory submissions, or other studiesSome tasks will be performed in a gowned, classified area including in +5°C or colder environments.Knowledge, Skills, and AbilitiesSuccessful candidates should have excellent communication skills (written and verbal), attention to detail, and the ability to be flexible and adapt to sudden changes in priorities and deadlines. He/she must have the ability to multi-task, work well under time constraints, and demonstrate consistent application of technical knowledge. He/she should also have basic knowledge/understanding of domestic (i.e. Food and Drug Administration) and applicable foreign regulatory agency requirements/guidelines.Preference will be given to candidates with knowledge of Quality release, pooling and/or fractionation processes and/or experience reviewing and approving others' work such as batch records, test data, reports etc.Required EducationQuality Associate II : BS/BA degree preferably in STEM (Science, Technology, Engineering, and Mathematics) discipline with a minimum of 2 years relevant experience, or equivalent combination of education and experience.Quality Associate III : BS/BA degree preferably in STEM (Science, Technology, Engineering, and Mathematics) discipline with a minimum of 3 years relevant experience, or equivalent combination of education and experience.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.Location: NORTH AMERICA : USA : NC-Clayton:USNC0002 - Clayton