Quality Inspector

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.

Job Summary:

Responsible for inspecting and sampling all raw materials that are used in production and packaging according to the Raw Material Specification (RMS) and associated approved procedures.

 

Primary job responsabilities:

• Sample raw materials for QC testing and for the Reference Sample program.
• Perform identification test for all chemical containers.
• Perform visual inspections and dimensional analysis of incoming materials per RMS.
• Record deficiencies associated with each lot received under the supplier quality history trending program.
• Review all inspection records to ensure entries are correct and completely fill out.
• Ensure all equipments used in the inspection and testing processes are calibrated.
• Maintain Instrument Usage and Calibration Logs based on instrument usage during the preparation and testing of samples.
• Monitor and maintain the inventory level of supplies used in the inspection process.
• Maintain work area and equipment in a clean, safe, and orderly condition.
• Exercise and Monitor GMP (logs, documentation practices, etc.) and safety compliance requirements in the work environment.

Knowledge, Skill and Abilities:

• Understanding of cGMPs, FDA regulations, and industry guidelines, as well as international regulatory guidelines.
• Ability to operate a forklift is preferred.
• Ability to keep neat, accurate and complete records and logs.
• Must be proactive, results oriented, with a strong attention to detail.
• Self-starter with good work ethic and ability to work independently with minimum supervision or as a contributing member of a team.
• Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever changing, fast paced critical work environment.
• Excellent verbal and written communication. Must be able to read, write, and speak English.
• Must be able to perform basic calculation such as addition, subtraction, multiplication, and division.
• Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner.
• Good computer skills with basic knowledge of Microsoft programs, particularly Outlook, Word, Excel, etc.
• Knowledge of SAP (Inventory Management System) is a plus. 

 

Educaiton and Experience:

• Minimum of High School diploma.
• Associates Degree in Chemistry, Biochemistry, or closely related scientific discipline is preferred. 
• Minimum of 0 -2 years of related experience. 
• Pharmaceutical industry experience or experience in a GMP or FDA regulated environment is preferred. 

 

Occupational Demands : 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