Specialist Manufacturing 35625

With minimal supervision, support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions. Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems.

• Knowledge in document handling on Veeva Vault (CDOCs) or similar platforms
• Technical writing expertise
• Change control handling (owner)
• Project handling
• Use of Smartsheet or similar platform
• Regulatory / GMP Knowledge
• Understanding of cGMP, compliance, and documentation practices for regulated industries.
• Bilingual (Spanish and English)

• →Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
• →Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities.
• →Provide troubleshooting support.
• →Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.
• →Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations.
• →Provide support of timely execution of the process monitoring quarterly reports.Non-Conformance and CAPA
• →Ensure that all non-conformances are triaged within the established goal.
• →Responsible for authoring investigation reports, execution of corrective actions and managing NC/CAPA closure within established goal.
• →Monitor and communicate incidents trends.
• →Review equipment/system Root Cause Analysis investigations and support trend evaluations.
• →Assist with generation of process validation protocols and reports and with the execution of the process validation.
• →Support collection and analysis of process validation data.
• →Participate in regulatory inspections, New Product Introductions, and Process or Equipment Modifications:
• →Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.
• →Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.
• →Assist manufacturing change owner on CCRB packages impacting the process.
  

• Master's degree with 2 years of Manufacturing Operations experience, a Bachelor's degree with 4 years of Manufacturing Operations experience, an Associate's degree with 8 years of Manufacturing Operations experience, or a High school/GED with 10 years of Manufacturing Operations experience.