Grifols · 1 month ago
Quality Associate II- III, QC
Grifols is a global healthcare company that has been working to improve health and well-being since 1909. The Quality Associate II-III, QC will provide technical support for the QC Sterility laboratory, including data analysis, decision-making, and employee training.
BiotechnologyHealth CareManufacturing
Responsibilities
Collects, reviews, and analyzes data
Makes decisions independently, but within a well-defined area
Addresses and resolves problems according to written procedure (i.e. SOP, etc.) or practice
Coordinates work activities and scheduling
Coordinates employee training
Communicates effectively and promptly at all levels of the organization, supporting department objectives and management decisions
Contributes cross-functionally within the departmental hierarchy
Demonstrates high levels of value and integrity
Follows cGMP and department safety practices
Apply expertise in testing to develop, validate and troubleshoot analytical methods
Serve as SME for laboratory assays and act as a resource for laboratory staff
Oversee the sterility aseptic gowning program
Perform investigations and write reports
Author SOPs and other laboratory documents
Collaborate with production and Quality Assurance and Compliance on projects, incident investigations, and annual product reviews
Evaluate data and perform statistical analysis for various projects
Serve as system administrator and SME for various laboratory information systems and applications as required
Overseeing the performance of all instrumentation utilized within the QC Sterility laboratory
Use instrument/assay knowledge to troubleshoot issues and to aid testing analysts
Oversee the purchase, installation and qualification of new instruments
Work with various instrument vendors to arrange service and overseeing vendor repairs and approval of service contracts
Work with various raw material and gowning supply vendors to arrange services, quotes and approval of contracts
Prepare analytical based reports as needed
Work in partnership with the QCAS laboratory to oversee the validation of new test methods (including drafting protocols, execution, drafting final reports, etc.)
Qualification
Required
BA/BS - preferably in a STEM (science, technology, engineering, or mathematics) curriculum and 2 yrs of relevant experience or an equivalent combination of education and experience
Detail oriented and great organizational and communication skills are a must
Excellent prioritization, multitasking and leadership skills are crucial
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 is 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
BA/BS - preferably in a STEM (science, technology, engineering, or mathematics) curriculum and 3 yrs of relevant experience or an equivalent combination of education and experience
Preferred
Experience testing/gowning/operating in a classified environment
Proficiency using SAP is strongly preferred
Prior experience with instrumentation, software and the data entry system used to perform Sterility testing and visual appearance assays
A strong technical aptitude and experience with Microsoft Word, Excel and SAP as well as technical report writing
Intermediate knowledge of Microsoft Excel and Word
Company
Grifols
Grifols is a global healthcare company.
H1B Sponsorship
Grifols has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2023 (2)
2022 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$2.51BKey Investors
Michael J. Fox Foundation
2025-01-14Grant· $21M
2024-06-04Post Ipo Debt· $1.41B
2024-04-23Post Ipo Debt· $1.07B
Leadership Team
Recent News
2025-12-24
Pharma Letter
2025-11-28
Company data provided by crunchbase