Quality Associate III/ Sr. Quality Associate I, QC (Sterility)

About the Role

Join an international team working to improve the future of healthcare. 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.

This position provides routine technical support for various tasks (i.e. documentation, training, compliance, test review, scheduling, etc.), assignments, projects, etc. for the QC Sterility laboratory. The role involves coordinating work assignments or training a small shift or group of employees in the Sterility laboratory. Hiring level will be dependent on experience level.

Primary 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

Additional Responsibilities

• 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

Qualifications for Quality Associate II

• 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
• Experience testing/gowning/operating in a classified environment
• Proficiency using SAP is strongly preferred
• Detail oriented and great organizational and communication skills are a must
• Excellent prioritization, multitasking and leadership skills are crucial
• 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. Example: If a job level requires a bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an associate's degree with 6 years of experience, or a master's degree with 2 years of experience

Qualifications for Quality Associate III / Sr. Quality Associate I

• 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
• The ideal candidate should be a fully qualified professional who requires minimal supervision and makes independent decisions within designated assignments
• Demonstrates high levels of integrity and value as well as consistent application of technical knowledge and expertise
• Addresses and resolves problems according to SOP and/or best practices and develops solutions to defined problems within area of assignments
• Communicates effectively and promptly with all levels of the organization, supporting department objectives and management decisions
• Prior experience with instrumentation, software and the data entry system used to perform Sterility testing and visual appearance assays (for example: closed canister filtration system, sterility testing peristaltic pump, visual light stations, etc.) is highly preferred
• A strong technical aptitude and experience with Microsoft Word, Excel and SAP as well as technical report writing is strongly desired

Additional Responsibilities for Senior Level

• 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.)

Work Environment & Physical 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 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