The Specialist Manufacturing will work under 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.
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. Ensure that all Non-conformances are triaged within the established goal. Responsible for authoring investigation reports. Responsible for execution of corrective actions. Responsible for 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. Assist with the execution of the process validation. Support collection and analysis of process validation data. May participate in regulatory inspections. 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. Participate on the assessment or implementation of special projects or initiatives.
Master’s degree and 3 years of Manufacturing Operations experience or Bachelor’s degree and 5 years of Manufacturing Operations experience.
Requirements & Skills
Ultimate Solutions Corp is an equal opportunity employer.
- Capacity of managing multiple tasks under pressure
- Proficient managing/editing documents in MS Word and Excel
- Detailed technical understanding of bioprocessing unit operations
- Skilled in performance of GMP production operations
- Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.
- ISO knowledge, understanding and experience
- Proficient in MS Word, PowerPoint, Excel, and Project
- Effective interactions in a team environment
- Team player, self-starter, persistent, tactful, and persuasive
- Good organizational skills, detail-oriented & accurate, analytical skills
- Effective verbal and written communication skills (writing and presentations)
- Fully Bilingual (English and Spanish)
- Able to work with minimum or no supervision