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Job Requirements of MS&T Specialist I:
-
Employment Type:
Contractor
-
Location:
Davie, FL (Onsite)
Do you meet the requirements for this job?
MS&T Specialist I
Careers Integrated Resources Inc
Davie, FL (Onsite)
Contractor
Job Title: MS&T Specialist I
Location: Davie, FL 33314
Duration: 12 Months+ (Possibilities of Extension)
Shift Schedule: Monday - Friday 8 am – 5 pm
Description:
#sczr2
Location: Davie, FL 33314
Duration: 12 Months+ (Possibilities of Extension)
Shift Schedule: Monday - Friday 8 am – 5 pm
Description:
- Core essential skill sets candidates must have to be considered for the role:
- College fresh PhD with chemistry
- Basic certifications in areas of Power Platform, AI, Project Management, preferred
- This position is responsible for performing activities related to critical aspects of products and processes with focus on process engineering.
- Maintains expertise related to process engineering and chemistry is necessary
- Digital literacy including basic knowledge of AI (working knowledge of PowerBI, Power
- Platform, Python and various presentation tools), JMP, R, etc. is necessary.
- 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.
- Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.
- Education/Certification/Experience:
- Requires a college fresh Ph.D. With chemistry
- Basic certifications in areas of Power Platform, AI, Project Management, preferred
- 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.
#sczr2
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