Manufacturing Trainer, Albumin Days
Social Circle, Georgia
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Manufacturing Trainer, Albumin DaysApply Now
The position will support the development of a new, state-of-the-art plasma processing facility that will bring Takeda additional cGMP capacity for fractionation, purification, filling, and packaging for its biologic medications. The Manufacturing Trainer position is responsible for developing trainees into qualified associates following company procedures. The trainer role will execute production activities in addition to other facility production training support, as needed. This position has sufficient technical and administrative competence to organize and lead production activities, including demonstrating leadership in state-of-the-art cGMP compliance, and environmental health and safety skills.
Provide on the job training and assisting with e-learning requirements.
Analyze training needs, monitor training compliance
Provide constructive feedback and coaching to associates.
Perform hands-on execution of manufacturing operations to support production schedule as needed.
Identify training gaps and developing a strategy to close them.
Anticipate problems or opportunities and implement proactive solutions.
May be required to write or revise SOP’s, Job Aids, Knowledge Assessment and Skills Assessments.
Contribute toward authoring SOPs, Job aids, and Structured on the Job Training (SOJT) associated to manufacturing processes.
Provide assistance to other Associates with SOJT and E-Learning requirements.
Manage and execute training interventions designed to solve specific training problems for either individuals or groups (Investigations, CAPA, Protocols)
May be required to develop specific training programs to help associates learn sustain and/or improve their job skills.
Support the implementation of Kaizen, Kanban and 5S systems to assist from CQV to Full production environment. Inform department managers of continuous improvement opportunities.
Contribute to a culture of safety first in compliance with Environmental, Health, and Safety (EHS) through all manufacturing associates and production engineers. Understand and follow Job Hazard Analysis (JHA) packets.
Train and explain process to others and ensure execution of processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply.
Must have Albumin purification experience. Must be able to read and follow detailed written/electronic instructions and have good verbal/written communication skills. Understanding of supplier/customer process streams and interdependencies, and be able to work on cross functional teams. Must have customer services and leadership attitude to take ownership of any maintenance related problem. Must be able to read, write and converse in English. Must be able to read and follow detailed written instructions and have good verbal/written communication skills. Must have good interpersonal skills, be able to work effectively and efficiently in a team environment and provide constructive feedback and coaching to other Associates. May require immunization before performing work within the manufacturing area. Must demonstrate importance of working in a regulated environment. Must have the knowledge and ability to use a personal computer, electronic mail systems and navigate and conduct searches on the intranet. Must have and display the following personal attributes: Integrity, trust, work ethic, sound Job Description Template 3 judgment, intellectual honesty, pragmatism, courage and conviction.
Experience in a regulated environment desirable. Must be qualified in at least one process function in Fractionation. High school diploma or equivalent required. Associate degree preferred. Must have working knowledge of GxP and training principles. Minimum 5 years of experience
Must be able to lift, push, pull and carry up to 50 lbs. Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body. No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the work Job Description Template 4 environment. May be working in a loud area that requires hearing protection and other protective equipment to be worn. Will work around chemicals such as alcohol that may require respiratory protection. May be required to work or be assigned to shifts as needed.
This job posting excludes CO applicants
LocationsUSA - GA - Social Circle - Hwy 278
Time TypeFull time
Job ID R0033067