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Quality Associate II/Quality Associate III

3 months ago

NCClayton, United States GRIFOLS, S.A. Full time

table.MiTabla { max-width: 1020px;important

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.

Job Description:

The primary area of responsibility will be the support of immunology and tissue culture assays for the QC Biochemistry laboratory.

Experience with biochemistry and biology assays is strongly preferred.  As a member of the Quality Control Biochemistry Methods Development & Validation group, the incumbent will perform or assist in the following:

  1. Biochemistry test method development, validation, transfer, and replacement
  2. Assay troubleshooting
  3. Instrument Qualification
  4. ICH test method validation status of test methods, and compliance issues related to QC Laboratories.

The incumbent will perform 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 through assay automation of test methods currently utilized for product release/specification testing.

Documentation will include but is not limited to, writing test procedures, test method validation reports, method development reports, and investigation reports.

 

Skill requirements:  

  • The incumbent must have hands on experience to support immunology and tissue culture assays for the QC Biochemistry laboratory and must have hands on experience in test method development and validation including preparing protocols and reports for such studies that are suitable for review by regulatory agencies.
  • The incumbent must have assisted in the replacement of test methods for improving assay performance and providing laboratory efficiency through assay automation of test methods currently utilized for product release/specification testing.
  • The incumbent must have demonstrated experience in the preparation of detailed technical reports including but not limited to test procedures, test method validation reports, method development reports, regulatory submission documents, and investigative reports.
  • 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 QC Biochemistry MD&V senior staff and to strive to provide creative solutions to problems that may arise during an investigation.
  • Experience within a GMP environment is strongly preferred.
  • The individual’s scientific area of expertise should provide an understanding of immunology and/or immunochemistry and of analytical methods including ELISA, spectroscopic techniques, and tissue culture methods.
  • 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.
  • A strong working knowledge of statistical data analysis is preferred.
  • Strong computer skills are essential, especially with MS Word, JMP, and Excel

Education Requirements:

  • The Quality Associate II requires a minimum of a PhD Biochemistry or Chemistry with minimal experience.  MS in Biochemistry or Chemistry with a minimum of 2 years relevant experience.  BS in Biochemistry or Chemistry with a minimum of 4 years of relevant experience. 
  • The Quality Associate III requires a minimum of a PhD Biochemistry or Chemistry and 1-year of relevant experience.  MS in Biochemistry or Chemistry with a minimum of 3 years relevant experience.  BS in Biochemistry or Chemistry with a minimum of 5 years of relevant experience.  

 

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.                                                                                                         

 

EEO Minorities/Females/Disability/Veterans 

 

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.

 

Location: NORTH AMERICA : USA : NC-Clayton:USNC0002 - Clayton 

 

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