For more info & to apply: Asst/Assoc Biologist - QC Sterility
Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.
Location: Clayton, NC
Shift: 1st Shift M-F 7:30AM to 4PM (Some Overtime Required)
The incumbent will perform biological testing of moderate to advanced complexity within the Quality Operations Laboratories in a safe, accurate, and efficient manner following established written procedures keeping complete and accurate records of the work and results. This position will be working primarily with the Closed Filtration System Sterility testing of Bulk and Final Container product in a class A/B aseptic environment according to established written procedures and following USP and EP regulations. This testing is required for the release of in-process materials and final containers. Maintaining complete and accurate records is essential. The testing takes place in a class A/B environment while wearing full coverage (space hood) class A/B aseptic gowning. Testing also includes daily visual observation of samples to determine microbial contamination and/or color appearance. This testing is very detail oriented.
Highly experienced with USP/EP Sterility testing preferred.
Highly experienced with operating in a class A/B Sterility Testing suite preferred.
Experience should include direct experience with Closed Filtration System Sterility Testing.
Experience performing visual appearance testing is also highly desirable.
Special Vision requirements apply to some areas. Must be able to successfully pass annual vision and aseptic gowning certifications.
Must be able to work aseptically and efficiently in full coverage gowning for extended periods.
Respirator certified or have the ability to become respirator certified.
Detail oriented and must be able to work independently with minimal supervision.
Excellent prioritization and multi-tasking skills are crucial.
Excellent written and verbal communication skills are also essential.
Must be able to interact well and maintain a professional relationship with peers.
Must have knowledge of GMPs and be able to apply excellent aseptic technique.
Experience with SAP and MODA is a plus.
Assistant Level: An Associate’s Degree in a life science field, medical technology, or related curriculum and a minimum of 6 months applicable laboratory experience or BS/BA degree in a life science field, medical technology, or related curriculum is required.
While the content of the course work specified above is generally applicable to the Assistant Biology position, the associated laboratory experience is more specifically applicable to the position's work assignments.
Associate Level: An Associate’s Degree in a life science field, medical technology, or related curriculum and a minimum of 2 years of college level biology courses (one year of general biology course(s) with associated laboratory work, and one year of microbiology course(s) with associated laboratory work, OR BS/BA degree in a life science field, medical technology, or related curriculum is required.
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.