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Clinical supplies, biologics, vaccines, electronic batch record review, batch record, cGMP, SOPs, specifications, labeling, regulatory submissions, SAP, Trackwise, Midas, Veeva, QMAS, QA, Quality Assurance.
$35 - $40 an hourFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Document Preparation: Draft, review, and file legal documents related to trust and estate matters, such as wills, trusts, powers of attorney, advance directives, and probate petitions. Our client offers a highly competitive compensation package with excellent benefits, including medical and dental coverage, a 401(k) plan, a Flexible Spending Account (FSA), group life and disability insurance, dependent care benefits, and paid vacation and personal time off.
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Review/approve creation/modifications to Master Stability Protocols (MSP) and Study-Specific Protocols (SSP), batch-specific enrollment documentation, and LIMS stability studies. Activities include (but not limited to) those associated with developing product stability strategy; stability data analysis/trending; and preparation, review and approval of stability protocols, reports and regulatory filings.
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Works independently, review data and demonstrated ability to recognize anomalous trends or results. Review and endorse change controls as required. The Stability Senior Scientist reports to the Senior Principal Scientist or Associate Director of GBS and is responsible for end-to-end oversight of product stability programs.
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For this initiative, this position will facilitate all communications and program aspects, from coordination with the Office of Enrollment Management for student review, through to enrollment, bridge semester activities, transition, and degree completion.
$86,471 - $129,099Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Use computer software/programs: Microsoft Office applications, SAP, LIMS, Quality Management System ( TrackWise or Veeva), JMP, etc. A thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (CFR) and their specific application to stability programs in a pharmaceutical manufacturing facility.
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Good organization skills and keen attention to detail Qualifications: (MS) or BS degree required with relevant cGMP experience in biopharma within a pharmaceutical manufacturing facility. Laboratory Information Management System (LIMS) Responsibilities:Accountable for end-to-end program management for biologics marketed product stability program, including: Stability product strategy: determines/communicates stability requirements ( Health Authority annual commitments, product/process change qualification batches, etc.
$64.15 - $69Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Preparation of Schedule Projection (What-if) and Time Impact Analysis per Regional Project Control Manager AcceptancePreparation of Critical Path and Variance analysis reports for review with Regional Project Control ManagerCoordinate, develop WBS dictionary with Project Accountant Manager.
$83,512 - $102,474 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Due diligence review of project contracts, including power purchase agreements, real property documents, corporate governance documents, EPC contracts, O&M agreements, and other contracts ancillary to the development, construction, acquisition, financing, and management of distributed energy solar and storage projects.
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Architectural Advisory & Review (Assessment -SABSA, TOGAF, CoBIT, Architecture assessment and review of solution architecture documentation, Desired Certifications - CISSP, SABSA, Cloud Security Architect, ISSAP.
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Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP's, CLIA/COLA and other applicable requirements. Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications.
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Responsibilities shall include, but are not limited to, the following: Overall project understanding, scheduling, contract document review, contract administration, assist in the development and execution of capital projects.
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Review product safety for its intended use and determine appropriate in vitro and clinical studies to substantiate safety. Conduct literature review and impact assessment on controversial safety and regulatory issues and provide recommendations to the management.
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Initiate change controls related to stability operations Provide the technical requirements in a Master Stability Protocol, review and approve study specific protocols and /or batch enrollment forms Responsible for the handling of annual commercial stability program for assigned products in coordination with sample management groups.
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We are looking for an ambitious and caring Back of House Director to join our team at Chick-fil-A. This "hands-on" management opportunity is designed to give you a career in the most highly-esteemed restaurant chain in the nation.
$150ExpandApply NowActive JobUpdated Yesterday
review job Title: medical director in Perth Amboy, NJ
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