Grifols Shared Services North America, Inc Quality Assistant Sample Specialist in Clayton, North Carolina
Grifols is a global healthcare company whose mission is to improve the health and well being of people. Our three divisions –Bioscience, Diagnostic and Hospital–develop, produce and market our innovative products and services to medical professionals in more than 100 countries.
We are committed to fostering an environment that creates continuous learning opportunities and encourages professional development and growth. As a company devoted to improving the health and well-being of people, we are looking for talented professionals worldwide. Make a difference and join us in this challenging and rewarding enterprise.
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.
● Ensures the accountability, GMP compliance, and delivery of all samples and associated documentation submitted for quality control testing, Responsibilities include: maintaining and auditing sample delivery logbooks; 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.
● Creates Certificates of Analysis within a laboratory based software or system
● 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.
SALARY GRADE: N6
MANAGER: Beth Barnes
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. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Light to moderate lifting and carrying objects with a maximum lift of 35lbs. Occasionally walks, bends and twists neck and waist, may reach above or below shoulder height. Frequent foot movements. Color perception/discrimination and near vision correctable in one eye to 20/30 and to 20/100 in the other eye. 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.
Location: [[mfield6]] : [[cust_building]]
Learn more about Grifols at http://www.grifols.com/es/web/international/home
Req ID: 75689
Type: Regular Full-Time
Job Category: Quality