Caresoft Inc. · 1 day ago
Scientific - Formulation Team Leader
Pompano Beach, FL
Contract
Onsite
Mid, Senior Level
$30/hr - $33/hr
2+ years expCaresoft Inc. is focused on ensuring regulatory compliance in the manufacturing of Reagent Red Blood Cells. The Formulation Team Leader is responsible for supervising the RBC Formulation Team, overseeing daily activities, ensuring product quality, and leading investigations related to non-conformances.
ConsultingInformation TechnologyLegalStaffing Agency
Responsibilities
Provide supervision for the RBC Formulation Team at MTS
Ensure flawless execution against the Quality System to ensure regulatory compliance with client’s global policies, international law and guidance
Oversee the daily Formulation scheduled activities at MTS as required to support Operations including creating weekly formulation schedules and delivery of intermediate buffers, diluents and solutions to be used in the manufacture of Reagent Red Blood Cells
Perform the formulation, filtration and testing of solutions, buffers and diluents used in the preparation of Reagent Red Blood Cells, and ensure these products meet specifications
Coach and mentor other associates in these duties
Perform inspection, preventative maintenance and calibration of instrumentation in the department
Perform timely review of batch records and forms to ensure solutions, buffers and diluents are available in a timely manner
Review forms for clarity and completeness ensuring the timely production release of components for further manufacturing
Participate in daily management team meetings and collaborate with Materials Management, Product Support, Facilities Management, Manufacturing, Quality Control Parameter Description Engineering to identify potential areas of process and product variability
Address Non-Conformances (NC's), Investigations, Root Causes Analysis by completing on time investigations in the Change Control System
Lead OOS Investigations and Document Revisions
Participate in all projects and initiatives undertaken at the MTS Site as a representative for the RBC Formulation department
Direct activities to ensure the RBC Formulation department is in a continued state of compliance and inspection readiness
Participate in Internal and External (FDA, TUV, and other Regulatory Agencies) Audits and represent the RBC Formulation department as a Subject Matter Expert
Perform transactions in the SAP Inventory System and other systems used in support of RBC manufacturing
Perform other work-related duties as assigned by the Department Manager
Qualification
Required
A minimum of An Associate of Science Degree in Medical Technology, Biology, Chemistry or Science related field of study
A minimum of 2-year experience at a medical or manufacturing facility
Any combination of education and experience
Experience working with chemical/biological formulations
Excellent oral and written communication skills
Basic knowledge of Microsoft Office suite of products (Excel, Word, Outlook)
Ability to prioritize and manage multiple tasks and challenges at the same time
Work independently and within a team environment
Preferred
Experience working in an FDA regulated environment
Experience in leading teams in a manufacturing environment
Company
Caresoft Inc.
Caresoft Inc. was founded in 1994 and is an enabler of innovation for organizations of all sizes.
201-500 employees
H1B Sponsorship
Caresoft Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (35)
2022 (1)
Funding
Current Stage
Growth StageLeadership Team
Arti Khare
Partner and Vice President
Recent News
2025-11-12
2025-06-24
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