Manufacturing Operations Specialist
hace 24 horas
We are seeking a skilled Manufacturing Operations Specialist to join our team at Kelly Services, Inc. near Juncos, PR. This is a 6-month contract opportunity with competitive compensation of $38/hour.
About the Role:
This dynamic position requires minimal supervision and involves supporting various manufacturing and quality systems including non-conformances, process validation, procedures, training, and new product introductions. You will apply your process, operational, scientific expertise, and basic compliance knowledge to ensure the efficiency and quality of our manufacturing processes.
Key Responsibilities:
- Applied Process Expertise
- Develop, revise, and approve manufacturing procedures to accurately reflect current operations.
- Analyze process performance through floor operations observation and data review, implementing process improvement solutions where needed.
- Provide expert troubleshooting support to resolve production issues.
- Create and deliver training materials on scientific or technical process aspects.
- Process Monitoring
- Evaluate process parameters and control limits, collecting and assessing process-monitoring data.
- Support timely execution and reporting of process monitoring quarterly reports.
- Non-Conformance and CAPA
- Triage all non-conformances in a timely manner.
- Audit thorough investigation reports.
- Execute corrective actions and manage NC/CAPA closure within established timelines.
- Monitor, communicate, and evaluate incident trends.
- Process Validation
- Assist in creating and executing process validation protocols and reports.
- Collect and analyze process validation data.
- Regulatory Compliance
- Potential participation in regulatory inspections.
- New Product Introductions & Process/Equipment Modifications
- Participate in the NPI process, evaluating documentation, materials, training, and equipment modification requirements.
- Manage and support process or equipment modification projects.
- Change Control
- Collaborate as a manufacturing change owner on CCRB packages impacting the process.
- Projects and Initiatives
- Participate in assessing or implementing special projects or initiatives.
Requirements:
We require candidates to possess either a Doctorate degree, Master's degree with 3 years of manufacturing operations experience, Bachelor's degree with 5 years of manufacturing operations experience, Associate's degree with 10 years of manufacturing operations experience, or High school diploma / GED with 12 years of manufacturing operations experience. Additionally, we seek individuals with an in-depth understanding of bioprocessing unit operations, proficiency in GMP production operations, knowledge of regulatory compliance, and exceptional communication and collaboration skills.
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