Grifols Shared Services North America, Inc Quality Associate II/III/Sr - Microbiology 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 primary area of responsibility will be support of the Quality Control Microbiology/Environmental Assurance/raw material Methods Development and Validation laboratory.

As a member of the Quality Control Methods Development & Validation group, the incumbent will perform or assist in the following:

  1. Microbiology and Environmental Assurance and raw material test method development, validation, transfer and replacement

  2. Executing study/validation protocols

  3. laboratory equipment troubleshooting/IOPQ

  4. Testing some non-routine samples

  5. Monitoring of global compendia and ICH method validation status of test methods

Specific requirements and job duties:

  • The incumbent must have initiated, directed, and implemented development and validation studies for test methods and prepare protocols and reports for such studies that are suitable for review by regulatory agencies.

  • The incumbent must have assisted in the replacement or transfer of test methods for improving laboratory efficiency.

  • The incumbent must have participated in the design of experiments and interpretation of data obtained through the course of an investigation under the direction of QCMD&V management.

  • The incumbent must have a strong understanding of microbiological test methods and have hands on experience in test method development and validation.

  • The incumbent must have hands on experience planning and executing assignments as well as authoring documents to define progress of projects and laboratory work.

  • The incumbent must have hands on experience with instrument qualification, software validation, and spreadsheet development and validation.

  • The incumbent must have hands on experience with kinetic endotoxin, sterility, TOC, and Bioburden. Experiences with particulate testing, GC, HPLC, and wet chemistry are 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.

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

  • Strong computer skills are required especially with MS Word and Excel.

  • Experience within a GMP environment is strongly desired.

Requirements:

Quality Associate II (M06) requires a minimum of a PhD in a Life Science or relevant degree with minimal experience. MS in a Life Science or relevant degree with a minimum of 2 years industry experience. BS in a Life Science or relevant degree with a minimum of 4 years industry experience.

Quality Associate III (M07) requires a minimum of a PhD in a Life Science or relevant degree and 1 year industry experience. MS in a Life Science or relevant degree with a minimum of 3 years industry experience. BS in a Life Science or relevant degree with a minimum of 5 years industry experience.

Senior Quality Associate (M08) requires a minimum of a PH.D in a Life Science or relevant degree and 2 years of industry experience. MS in a Life Science or relevant degree with a minimum of 4 years of industry experience. BS in Life Science or relevant degree with a minimum of 6 years of industry experience

An advanced degree is preferred.

Shift: Day

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.

EEO Minorities/Women/Disabled/Veterans

Location: [[mfield6]] : [[cust_building]]

Learn more about Grifols at http://www.grifols.com/es/web/international/home