Sr. Quality Associate

Company: Grifols

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.

Hours

First Shift - Monday to Friday 8:00 am to 4:30 pm

Job Responsibilities

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

Preferred

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:

• Biochemistry test method development, validation, transfer, and replacement
• Assay troubleshooting
• Instrument Qualification
• ICH test method validation status of test methods, and compliance issues related to QC Laboratories.
• Change control process
• Reports and procedure writing

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
• Qualified author or equivalent experience.
• Experience working with cross-function teams on projects.

Note: This position requires the individual to prove they are immunized against measles, polio, virus and diphtheria toxin or they will have to get immunized by Grifols Health Services.

Education Requirements

• Senior Quality Associate (M08) requires a minimum of a Ph.D. in Biochemistry or Chemistry and 2 years of relevant experience. MS in Biochemistry or Chemistry, and 4 years of relevant experience. BS in Biochemistry or Chemistry, and 6 years of relevant experience.

Work Environment

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.

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.

Equal Employment Opportunity

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

Learn more about Grifols.