Grifols Shared Services North America, Inc Aseptic Filling Coordinator - 2nd shift - 3:00pm-11:00pm in Clayton, North Carolina
For more than 75 years, Grifols has worked to improve the health and well-being of people around the world. We are a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to deliver expert medical care.
Headquartered in Barcelona, Spain, Grifols has nearly 18,500 employees in 30 countries. Grifols’ three main divisions - Bioscience, Diagnostic and Hospital - develop, manufacture and market innovative products and services available in more than 100 countries.
A leader in transfusion medicine, the Diagnostic Division is a global business focused on providing innovative solutions to help ensure the safety of the blood and plasma supply, detect human diseases and monitor therapies. The division advances patient care with diagnostic solutions to improve disease detection and management, and simplify laboratory operations.
Aseptic Filling Coordinator
The Coordinator performs complex tasks within a GMP environment ensuring the utilization of the area and personnel are at peak efficiency and all activities are conducted in a safe environment. He/she is responsible for assisting the supervisor in implementation and enforcement of departmental and company policies and may be called upon to be the supervisor’s delegate in their absence.
*Performs all duties described at the Aseptic Filling Technician III Level.
*Works with the supervisor to maintain availability and proper utilization of production materials required for the filling process.
*Follow and enforce the procedures outlining production, facilities and equipment.
*Follow-up on tasks to ensure completeness/correctness. Ensure production is carried out within specified timelines.
*Print, review and approve reports related to production processes.
*Performs tasks related to document issuance (Runbooks) and SAP inventory controls.
*Assist with responses and corrective actions related to audit/inspection observations.
*Enforce real-time documentation by performing audits of documentation during the production run.
*Responsible for creating and balancing the workflow of the day to include break assignments, PTO, etc.
*Works with assigned team to organize production events to ensure the safe and expedient completion of the production process.
*Works with the Department Manager and Supervisor to implement and enforce department and company policies.
*Serves as a stand in for the supervisor in their absence, relied on to maintain harmony within the department.
*Assist Supervisor and Training with monitoring and maintaining training responsibilities for the Technicians.
*Maintaining all training responsibilities associated with the Coordinator level.
Knowledge, Skills, and Abilities
*Proficient use of Microsoft Office programs such as Word, Powerpoint, and Excel, mechanical aptitude, detail oriented, ability to work in a team environment and exercise good judgement while working independently.
*High school diploma or equivalent plus Bioworks certificate or high school diploma or equivalent plus at least 1 year of experience in a regulated environment (i.e. FDS, USDA, NRC)
Internal Candidate Requirement: Must be at a minimum Technician III level and must have a minimum PMP rating of “achieves expectations". Demonstrated ability to operate as a lead of work activities and people. In addition, required for Filling employees at the Technician Level II level: Certified to operate in the fill room and able to operate aseptic fill environment equipment such as the fill machine and ALUS independently. *GSF Filling experience preferred.
Work is performed in a manufacturing environment with rotating shifts. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to chemicals and to electrical manufacturing equipment and moving machinery. Exposure to high levels of noise. Occasional entry into confined spaces, requiring kneeling and squatting. Personal protective equipment required such as; protective eyewear, chemical suits, safety shoes and/or rubber footwear, gloves, hearing protection and a respirator. Work is performed sitting for 4-6 hours per day. Occasionally walks, stands and bends waist for 2-4 hours per day. Frequent hand movement of one hand 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 of 15-44lbs. for 1-2 hours per day with a maximum lift of 50lbs. May reach above and below shoulder height. Hearing acuity essential. Color perception/discrimination, far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate 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. Frequently performs simple and routine tasks that vary little each day by following a set of written or oral instructions/procedures.
Location: [[mfield6]] : [[cust_building]]
Learn more about Grifols at http://www.grifols.com/es/web/international/home