MS&T Specialist I
2 weeks ago
At Cogent Infotech, we believe in creating opportunities that empower individuals and transform organizations. With over 21 years of excellence in consulting and talent solutions, we pride ourselves on building inclusive workplaces and driving innovation in everything we do. Our diverse teams bring unique perspectives to help deliver cutting-edge solutions to global clients across both pubalic and private sectors
Title: MS&T Specialist I
Location: Davie, FL
Job Description:
- All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.
- Coordinate manufacturing of batches if required and prepare technical reports.
- Performing continuous process and cleaning verification, statistical assessments and trend analysis for the development and commercial products.
- Performing investigations to identify the root causes and actively seek remediation approaches and implement Corrective and Preventive Actions (CAPAs).
- Provide Technical assessments/ product impact assessment summaries on time to avoid back-order situation.
- Execute the experimental and process confirmation studies in coordination with planning, manufacturing, quality, LTS and PM groups.
- Review and analysis of the analytical and statistical data to support the pre-validation work. Analysis of data to ascertain the data meets protocol and product acceptance criteria: writes deviation reports and technical assessments as required.
- Supports pre-validation commercial scale report that includes detailed summary of the equipment and qualified equipment parameters (QEPs) assessment, CPPs and CQAs identified during pre-validation work.
- Participation in internal (Corporate and QA audits) and external (FDA, MHRA) audits.
- Remediation of the audit related observations (if any) and timely completion of the action items (if any)
- Maintenance of appropriate documentation of protocols, reports, and laboratory notebooks as required by Standard Operating Procedures (SOPs) and internal policies.
- Actively participate in commercial pre-validation and provide technical support to the manufacturing and quality teams as required.
- Leading multiple new product introduction, site transfer projects and cleaning validation activities.
- Responsible for completing all training requirements and maintaining 100% compliance with all assignments.
- Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP's), and Standard Operating Procedures (SOP's) and Batch Record instructions.
- Responsible for performing additional related duties as assigned.
- Ability to prepare various types of complex high quality technical documentation (Batch Records (BR), Change Controls (CC), protocols, summary reports, technical assessments, validation reports and deviation/investigation reports etc.
- Ability to handle multiple projects, duties, and assignments.
- Solving practical problems and considering a variety of concrete variables in situations where only limited standardization exists.
- Education/Certification/Experience:
- Requires a college fresh Ph.D. With chemistry
- Basic certifications in areas of Power Platform, AI, Project Management, preferred
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