Manufacturing Specialist IGIV Bulk

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.

In general, the Manufacturing Specialist is responsible for performing the essential administrative functions that support the manufacturing operations. The Manufacturing Specialist will work in conjunction with the Manager, Manufacturing to coordinate all logistics pertaining to manufacturing operations. Furthermore, this position will be responsible for assisting in document review and process trending.

• Perform daily data entry functions within the SAP system.
• Request and maintain all documents relating to manufacturing, i.e. MWOs (Manufacturing Work Order), MSOs (Manufacturing Support Order) and other appropriate logs.
• Works with the department manager to maintain the production schedule.
• Request and coordinate all materials required for the manufacturing operations.
• Request and maintain all administrative and safety supplies for the department.
• Document, trend and report the department KPI’s (Key Performance Indicators) within the appropriate databases.
• Organize and maintain the department document archives.
• Assist the department manager with various administrative tasks.
• Strict adherence to procedures and practices according to FDA regulations.
• Strong emphasis on documentation according to FDA regulations.
• Adhere to departmental corporate safety policies.

• High school diploma or GED required. Associate’s degree, applicable certification, and/or military veterans preferred.
• Minimum of 2 years of related experience in a pharmaceutical, GMP, or FDA regulated environment is required. Administrative and high volume data entry processing experience is preferred.
• Requires basic understanding of pharmaceutical manufacturing operations and high volume data entry processing.
• Comprehensive knowledge and understanding of cGMPs, FDA regulations, and industry guidelines.
• Ability to work independently with minimum supervision.
• Must be proactive, results oriented, and have strong attention to detail.
• Self-starter with strong work ethic and the ability to exercise good judgment.
• Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines.
• Strong interpersonal skills with the ability to interact with personnel at all levels in a team environment.
• Must be able to read, write, and speak English.
• Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
• Must be flexible with working hours / shifts in order to accommodate the 24 hour, 7 day plant operation.
• Specific experience with SAP or other inventory management systems is preferred.

Work is performed in a manufacturing environment or warehouse with rotating shifts. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to chemicals, electrical manufacturing equipment, hand tools and moving machinery. Operates forklifts, tractors and power equipment. Exposure to high levels of noise and to dust/gas/fumes/steam. Exposure to extreme cold below 32
* and on occasion, exposure to extreme heat above 100*. Exposure to vibration or oscillating movements of the extremities or the whole body. Occasional entry into confined spaces, requiring kneeling, crawling, climbing and squatting. Works at heights on scaffolding and/or on ladders. Walks on uneven ground. Personal protective equipment required such as; protective eyewear, chemical suits, safety shoes and/or rubber footwear, gloves, hearing protection and a respirator.

Heavy lifting and carrying of 45lbs. for up to 6-8 hours per day, with a maximum lift of 75lbs. Work is performed standing, walking, bending and twisting waist for 4-6 hours per day. Frequent foot movements. Occasionally reaches above and below shoulder height. Occasionally bends and twists neck. Frequent hand movements with simple grasping of one hand with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.

Ability to make precise coordinated movements, of the fingers to grasp and manipulate…