Specialist Manufacturing

hace 2 semanas


Juncos, Puerto Rico Biopharma Consulting Jad Group A tiempo completo

We are seeking a skilled and proactive Manufacturing/Quality Systems Specialist to join our team.
This role requires minimal supervision and involves supporting the execution of manufacturing and quality systems, including non-conformance management, process validation, procedural development, training, and new product introductions.
The ideal candidate will apply their expertise in process operations, scientific principles, compliance knowledge, and troubleshooting to enhance manufacturing processes and ensure adherence to standards.
They may serve as the primary production process owner for key support systems and assist with responsibilities for more complex processes.
Responsibilities Initiate, revise, and approve manufacturing procedures to ensure alignment with current operations, act as the document owner.
Monitor process performance by observing operations and reviewing performance data to identify and implement process improvements.
Provide troubleshooting support to address operational challenges.
Assist in the creation of training materials and deliver training on scientific or technical aspects of processes.
Support the establishment and evaluation of process monitoring parameters and control limits.
Collect and assess process-monitoring data while contributing to the preparation of quarterly reports.
Triage non-conformances promptly, meeting established goals.
Author detailed investigation reports and execute corrective actions.
Manage the closure of non-conformance (NC) and Corrective and Preventive Actions (CAPA) within deadlines.
Monitor, analyze, and communicate incident trends.
Review root cause analysis investigations and evaluate trends in equipment or system performance.
Assist in creating and executing process validation protocols and reports.
Support the collection and analysis of validation data.
Participate in regulatory inspections as needed to ensure compliance.
Collaborate during the NPI process to evaluate documentation, materials, training, and equipment requirements.
Prioritize, justify, and manage projects involving process or equipment modifications.
Support manufacturing change control processes by assisting change owners in preparing CCRB packages.
Participate in the assessment and implementation of special projects and initiatives that drive process improvements.
Key Competencies and Skills Deep understanding of bioprocessing unit operations and GMP production workflows.
Proficient in regulatory compliance and interactions.
Strong communication and collaboration skills to engage with technical and management staff.
Advanced organizational, technical writing, and presentation abilities.
Basic project management knowledge and control charting expertise.
Proven ability to lead and participate in cross-functional teams.
Requirements Education and Experience Doctorate degree OR Master's degree with 3+ years of manufacturing operations experience OR Bachelor's degree with 5+ years of manufacturing operations experience OR Associate's degree with 10+ years of manufacturing operations experience OR High school diploma/GED with 12+ years of manufacturing operations experience.
Preferred Qualifications Hands-on experience managing CAPAs in manufacturing settings.
Expertise in change control management and project management.
Strong background in risk management and documentation of deviations.



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