Intellectt
Intellectt

78 Intellectt Operations Jobs Hiring Near You

CNC Fabrication Engineer

Peoria, IL · On-site

$71K - $91K/yr

My name is Vyshu, and I'm reaching out from Intellectt Inc. regarding an exciting contract ... operations. The role involves CNC programming, fixture development, process improvement, and ...

Lead

Dallas, TX · On-site

My name is Vyshu, and I'm reaching out from Intellectt Inc. regarding an exciting contract ... Experience in shipping, receiving, logistics, or warehouse operations. * Knowledge of customs ...

My name is Mahalakshmi, and I'm reaching out from Intellectt Inc. regarding an exciting contract ... Support startup, troubleshooting, and operational readiness activities. * Review P&IDs, vendor ...

PLC Controls Engineer

Peoria, IL · On-site

$76K - $98K/yr

My name is Vyshu, and I'm reaching out from Intellectt Inc. regarding an exciting contract ... Work closely with engineering and operations teams Qualifications * Engineering Degree or related ...

Manufacturing SME

Lebanon, IN · On-site

$69K - $90K/yr

My name is Mahalakshmi, and I'm reaching out from Intellectt Inc. regarding an exciting contract ... expertise to support manufacturing operations and continuous improvement initiatives.

Controls Design Engineer (BMS)

Pelzer, SC · On-site

$62K - $81K/yr

My name is Vyshu, and I'm reaching out from Intellectt Inc. regarding an exciting contract ... Develop schematics, I/O lists, sequence of operations (SOO), and control drawings * Collaborate ...

Process Manufacturing SME

Lebanon, IN · On-site

$70K - $93K/yr

My name is Vyshu, and I'm reaching out from Intellectt Inc. regarding an exciting contract ... expertise to support manufacturing operations and continuous improvement initiatives.

This is Mahaboob from Intellectt INC; we've got an important Automation Engineer - Libertyville, IL ... Collaborate with engineering/operations for process improvements * Support new product automation ...

Automation Technician

Buffalo Grove, IL · On-site

$43K/yr

This is Mahaboob from Intellectt INC; We have an urgent opening for a Automation Technician ... Record procedures, test results, and operational data. * Maintain software, equipment documentation ...

Showing results 61-78

Operations Batch Review Specialist

Operations Batch Review Specialist

Intellectt INC

Bloomington, IN • On-site

Contractor

Posted 6 days ago


Job description

Hello,
I hope you’re doing well.
My name is Jayadev, and I’m reaching out from Intellectt Inc. regarding an exciting contract opportunity for a Operations Batch Review Specialist based in Bloomington, Indiana with one of our prestigious clients.
I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at  jayadev.g@intellectt.com
 
Title:Operations Batch Review Specialist
Location:  Bloomington, 
Indiana
The Operations Batch Review Specialist is responsible for reviewing batch documentation post execution to ensure that all work completed was carried out in accordance with regulatory requirements, Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs) while maintaining the highest possible quality standards. This position will work directly with the operations team and provide coaching and feedback for corrections and documentation improvements. This position will also work closely with the quality systems team to provide information and/or feedback for manufacturing deviation investigations and CAPA implementation.
The Operations Batch Review Specialist will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences.  They will thrive in a team environment but will also work autonomously utilizing strong self-management and organizational skills.  Additionally they will value process owners and subject matter experts and will possess a demonstrated ability in influencing positive outcomes without direct reporting authority.
Essential Job Functions:
  • Full batch documentation review of parenteral manufacturing Batch Records (Formulation, Filling, Inspection, & Packaging) for Media Fills and Drug Product.
  • Identify correction, deviations and escalate found issues to Operations and Quality Supervisors.
  • Provide training and feedback to Operators and Supervisors to improve on-the-floor Batch Record reviews during execution.
  • Support Quality Systems with driving timely completion of batch impacting deviations to support on time batch release activities.
  • Initiate deviations and participate in operations investigations for determining root cause and assessing mitigation for deviating events.
  • Support authoring, reviewing and approving of various SOPs & Work Instructions.
  • Prioritize and coordinate their record reviews within production timelines.
  • Utilize various paper and automated systems (eDMS, SCADA, BMS, CMMS, LIMS, lab instrument software, etc.) to ensure data integrity in batch records.
  • Ability to manage multiple projects in a fast-paced environment.
  • Exemplify and take proactive approaches in terms of safety expectations, practice positive intervention, and enforce best practices that align to SOPs, compliance requirements, quality guidelines, and site goals.
Special Job Requirements:
  • Knowledge of process control, quality engineering, sampling requirements, statistical techniques, and process capability
  • Familiarity with relevant quality and regulatory requirements and trends and cGMP's
  • Strong communication skills and the ability to build relationships with colleagues across all levels of the organization, including business managers, operations leaders, and technical leaders.
  • 4 years minimum experience working in a GMP environment.
  • Excellent written and verbal communication skills.
  • General computer skills evidenced by hands-on work with computerized Operations equipment (SCADA); and reporting and data analysis software (Word, Excel, Visio, JMP, Minitab, etc
Additional Preferences:
  • Experience as performer or reviewer in Quality Management Systems
  • Experience with assessment and review of Quality Control testing, CoA, and results management preferred.
  • Knowledge of regulations and quality processes involving product disposition.
Thanks Regards,
JAYADEV
Sourcing Specialist
Phone  (732)-997-6982   Ext: 308
Email jayadev.g@intellectt.com