United States Job Openings
BI AH Puerto Rico, LLC
Packaging Process Leader
State Road
FULL TIME
September 6, 2024
Duties & Responsibilities
- Manage and verify packaging components, printed components, bulk product, finished product and waste (following special precautions per product).
- Document clear and correct the information and data of the packaging process for each lot.
- Keep packing lines clean, identified and organized, including hallways and cleaning room.
- Perform inspections and sampling of blisters following the sampling plans specified in the operational procedures for the packed product.
- Post, manage and reconcile materials and waste at the end of the packaging process of each batch, registers information and data in the documents assigned for it.
- Operate and clean the equipment used in the packaging process on the different packaging lines.
- Operate and enter information relevant to the product to be packaged to the computerized equipment in the packaging area.
- Perform major and minor cleanings efficiently and effectively following operational procedures. Properly document cleanings in the cleaning log for each line.
- Must use the provided safety equipment.
- Inform the supervisor or designated of any deviation or potential hazard in the area.
- Properly complete other tasks assigned by the supervisor or designee.
- Perform basic 'troubleshooting' of pharmaceutical packaging equipment in a controlled automated environment. Assemble and disassemble the mechanical equipment as required.
- Supply the materials to the storage accumulators when assigned.
- Assist in documentation audits of packaging logs and atypical event investigations.
- Provide support in other quality activities such as the assessment of the elegance test and others.
- Keep work areas clean and safe to ensure Good Manufacturing Practices (including good practices of identification of equipment) and good cleaning practices.
- Assist technical staff and other team members with qualification validations, documentation of atypical event investigations and observations, implementation of corrective actions and area of samples as required.
- Provide support for process improvement or facilities aimed at reducing costs, performance and product quality.
- Perform material reconciliation and complete documentation of usage and waste.
- Perform material transactions through the inventory system as required.
- Follow the 'lock-out', 'tag-out' procedures to the applicable equiment before working on them.
- Follow the general safety procedures of the plant, in addition to maintaining the personal safety equipment in optimal conditions.
- Inform the dispensary of any medical conditions that may affect the good execution of the tasks. In case of recommendation of the supervisor, the incumbent should attend the medical dispensary for an evaluation.
- Keep metrics area up to date.
- Comply with all environmental guidelines, procedures, trainings, practices, permit conditions and internal notification of any environmental incident.
- Segregate, manage and identify waste such as non-hazardous and hazardous material. Maintain regulatory documentation.
- Coordinate the packing activities and support the supervisor if necessary in activity coordination tasks.
- Provide on-the-job and procedural training (SOPs) to assigned personnel.
- Ensure that ergonomic rotation plans are performed, as well as other tasks or activities as required by the supervisor.
Requirements
- High school diploma is required.
- Associate degree or technical or university studies is preferred.
- Experience in manufacturing processes, packaging, and/or material handling, as well as prior knowledge and experience in quality inspections and sampling, c GMP documentation and reconciliation of components, materials and products.
- Operational knowledge of the SAP inventory system.
- Basic Knowledge of Office (Word, Excel, Power Point, Outlook) preferable.
- Knowledge of c GMP ' EHS regulations, pharmaceutical packaging processes and related documentation.
- Language proficiency in spanish (read, write, speak) and basic knowledge of the English language (understand basic verbal and written instructions).
- Ability to identify conflict situations and communicate them to supervisory staff.
- Willingness to promptly raise concerns and situations that may affect the working environment.
- Able to read and interpret written documents and procedures.
- Must be able to promote teamwork skills in the assigned group.
- Ability to provide clear and understandable instructions.
- Math skills, including to: add, subtract, multiply, divide, calculate percentages, and manage fractions.
Eligibility Requirements
- Must be legally authorized to work in the United States without restriction.
- Must be willing to take a drug test and post-offer physical (if required).
- Must be 18 years of age or older.
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