Training Leader QA Compliance
Baxter International
- Location
- Aibonito, Puerto Rico
- Work model
- On-Site
- Level
- Mid
- Posted
- 22h ago
About this role
This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. Shift: A Summary: Provide training using the Job Instruction Breakdown procedures and specifications of the designed area to regular, temporary, part-time, contractor and transfer personnel. Assist supervisor in clerical duties. E ssential Duties and Responsibilities: Coordinates the training, certification, and re-certifications process of employees in his/her designated area. Responsible in certifying area department instructor and process engineer at the start of a new process. Responsible for data entry and monitoring of employees training records on to BAXU Training System. Maintain file control of corresponding area employee manual certification records. Maintain file control of each employee manual certification records and assure employees are certified in their designated areas as needed. Review in conjunction with supervisor and process engineer the Training Manuals Procedure every two years. Certifies employee’s assembly techniques by taking samples and inspecting them. Maintains documentation controls of process. Has active participation in plant working team. Analyzes area complaints with supervisor. Create, maintain and follow up Training Matrixes and Modules per position in BAXU. Support safety chats. Provide line support (TIQ, Group Leader) when necessary and assist in employee rotation in the different assembly techniques. Support the annual GMP orientation to employees that do not attend initial training. Reports to the Training Manager or Area Supervisor of the corresponding department for task assignments. System verification of employees’ certification in “x” operation especially when the engineer validates equipment, assuring the protocol is run with certified personnel. Verified with Process and Product Engineering Dept., changes in the manufacturing process or equipment validations. Assure all personnel training and certification are updated if validations and modifications have been modified. Manually document (ex: checker chart) and/or electronically (ex: POMs) the required information to comply with applicable procedures and specifications. This information includes, but is not limited to, process parameters, lots, amount of production, and others. Ensure that the different areas comply with SOL6’S Program Actively report health and safety hazards, environmental aspects, incidents, and EHS management system risks and opportunities. Participate in the development, planning, implementation, performance evaluation and actions for continuous improvement of the EHS Management System.
Qualifications
Knowledge in computerized systems. Must be knowledgeable of GMP, Specifications and SOP's related. Good communication and interpersonal skills.
Physical Demands
Light Work : Exerting up to 20 pounds of force occasionally and/or a 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects. Physical demands requirements are in excess of those for Sedentary Work. Even though the weight lifted may be only a negligible amount, a job should be rated Light Work: (1) when it requires walking or standing to a significant degree; or (2) when it requires sitting most of the