Grifols Shared Services North America, Inc Quality Associate II / III / Sr Quality Associate I in Clayton, North Carolina
For more than 75 years, Grifols has worked to improve the health and well-being of people around the world. We are a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to deliver expert medical care.
The primary area of responsibility will be support of the QC Plasma Chemistry and Raw Materials laboratories.
As a member of the Quality Control Methods Development & Validation group, the incumbent will perform or assist in the following:
Raw Material test method development, validation, transfer, and replacement
Chemistry test method development, validation, transfer, and replacement
ICH test method validation status of test methods, and compliance issues related to Quality Control Laboratories.
Any new product/project test method development and validation.
Regulatory submission documents generation or review
• The incumbent will direct and implement validation studies for assay methods and prepare protocols and reports for such studies that are suitable for review by regulatory agencies.
• The incumbent will assist in the replacement or transfer of test methods for improving assay performance and providing laboratory efficiency.
• Documentation will include, but is not limited to, writing test procedures, test method validation reports, method development reports, and investigation reports.
• The incumbent must have hands on experience to support Chemistry assays for the QC Plasma Chemistry and Raw Materials laboratories and must have hands on experience in test method development and validation.
• The incumbent must have hands on experience planning and carrying out assignments as well as author documents to define progress of project and lab works.
• The incumbent is expected to participate in the design of experiments and interpretation of data obtained in the course of an investigation under the direction of QCMD&V senior staff and to strive to provide creative solutions to problems that may arise during an investigation.
• Experience within a GMP environment will be an asset
• The individual's scientific area of expertise should provide a strong understanding of Chemistry methods used to test Plasma Derived Product and Raw Material samples.
• The incumbent must have hands on experience with instrument qualification, software validation, and spreadsheet development and validation.
• Experience with protein analysis, purification, and characterization will be considered a plus.
• The incumbent must have strong oral and written communication skills, with the ability to effectively communicate ideas to people with varying degrees of technical understanding is essential.
• Strong computer skills are preferred or required especially with MS Word and Excel.
Strong communication skills in writing and oral
Quality Associate II (M06) requires a minimum of a PhD in Chemistry with minimal experience. MS in Chemistry with a minimum of 2 years relevant experience. BS in Chemistry with a minimum of 4 years relevant experience.
Quality Associate III (M07) requires a minimum of a PhD in Chemistry and 1 year relevant experience. MS in Chemistry with a minimum of 3 years relevant experience. BS in Chemistry with a minimum of 5 years relevant experience.
Senior Quality Associate (M08) requires a minimum of a PH.D in Chemistry and 2 years of relevant experience. MS in Chemistry, and 4 years of relevant experience. BS in Chemistry, and 6 years of relevant experience
Salary Grade: M06 / M07 / M08
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: 73788
Type: Regular Full-Time
Job Category: Quality