Clayton, NC, 27528, USA
12 days ago
Quality - Assistant Sample Specialist
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: 2nd - 1:30 pm - 10:00 pm** The Assistant Sample Specialist functions as an initial reviewer and establishes acceptability of samples for all samples requiring quality control testing. This includes, but is not limited to: raw plasma, vendor intermediates, chemicals, process intermediates, and final product. This position is responsible for the accountability, delivery, GMP compliance, and investigation of discrepancies for all samples and associated documentation as well as the issuance of the required non-electronic quality control testing documentation. This is done by verifying the integrity and of the quality control laboratory’s incoming samples, documentation is complete and accurate documentation, and that all samples meet set specifications to ensure that the safety and efficacy of the final product are not compromised or adulterated. Accurate and timely performance of these functions are required to support and directly impact the quality of testing for: in-process, bulk, and release samples; stability samples; process characterization samples; process development; process validation; assay development; non-routine sample testing; and special projects. **Responsibilities:** ● Ensures the accountability, GMP compliance, and delivery of all samples and associated documentation submitted for quality control testing, Responsibilities include: Auditing all sample labeling and documentation for accuracy and GMP compliance; transport of samples and sample documentation to various quality laboratories; conducting investigations to resolve and document GMP errors or other discrepancies associated with sampling, labeling, and/or sample documentation. ● Interfaces directly with personnel from various departments in order to correct deficiencies and facilitate delivery of samples for laboratory testing. ● Perfom data entry in Microsoft Office, SAP and STIS. ● Resolves sample discrepancies directly with internal and external customers. Sample Specialists must be familiar with a wide variety of systems and procedures in order to review and accept quality test materials. Extensive knowledge of cGMPs, Grifols specifications, and distribution operating procedures is also required. The incumbent must possess keen assessment skills and the ability to distinguish insignificant deviations from significant deviations that jeopardize the integrity of the material to be released. Computer skills are required. Effective communication skills, including proper grammar, are essential in order to report (both in writing and verbally) data and product impact. Must keep neat, accurate, and complete records of materials evaluation and sample activities performed. Tactful human relation’s skills are essential to achieve cooperation between QC, QA, Manufacturing, and vendors. When working with raw material chemicals, must be able to wear all required safety equipment and able to work with limited supervision. Must demonstrate initiative and have the ability to defend a decision based on specifications and procedures against pressure from higher levels of management. Fundamental knowledge of math and science: chemistry, biochemistry, biology. **Requirements:** An Associate’s Degree with an emphasis in a scientific field is required. An equivalent combination of education and experience is acceptable. Working experience in pharmaceutical industry under GMP and GLP and knowledge of human plasma product are needed. Knowledge and skill using computer word software is essential. Excellent oral and written communication skills is required. Extensive knowledge of cGMPs, product specifications, and distribution operating procedures is preferred. 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 and a laboratory/manufacturing environment or warehouse. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to occasional extreme cold below 32* in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Work is performed sitting or standing for 2-4 hours per day. Light to moderate lifting and carrying objects with a maximum lift of 35lbs. Frecuent walks, bends and twists neck and waist, may reach above or below shoulder height. 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, 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:** 519368 **Type:** Regular Full-Time **Job Category:** Quality
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