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Provide office support for data management, report preparation, and maintenance of the required AECOM-related documentation and forms. The candidate will conduct soil and groundwater investigations and remediation projects in accordance with Comprehensive Environmental Response, compensation, and Liability Act (CERCLA), the Resource Conservation and Recovery Act, various NCDEQ Division of Waste Management Programs and other regulatory programs.
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Key responsibilities are performing GMP tasks associated with maintaining compliant Quality Control and Stability laboratories; providing sample management support for QC; and creating, reviewing and approving documentation.
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Other responsibilities include cGMP documentation, sample login, data review, instrument maintenance, and other tasks assigned by management. The individual will perform technically diverse testing and analysis with minimal assistance using modern instrumental analytical techniques including but not limited to coagulation assays, enzymatic assays, immunoassays, chromatography (HPLC, GC, IC), capillary electrophoresis, and gel electrophoresis.
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You will be responsible for leading QC in partnering with CDMOs to meet testing timelines and support overall processes across sample management, documentation, and compliance. Expertise in technical writing across analytical and QC documentation including working knowledge of regulatory standards across the globe.
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Distributing samples, which involves removing from stability chambers samples scheduled for testing, coordinating sample labels, packing samples into appropriate containers per specified storage/shipping conditions, adding appropriate documentation, physically delivering samples to designated locations or coordinating international and domestic shipments, initiating electronic shipment requests, and coordinating with recipients.
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Degree must be within a relevant field: (Biology, Biochemistry, Chemistry, or Toxicology) Masters plus 1 year of relevant experience, or Bachelors plus 3-4 years of relevant experience, No degree requires 7 years of relevant experience.
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Determines the methods/devices that will be used for inspection Collaborates with Manufacturing Engineer/s to assess the critical product characteristics that will be measured Applies statistical process control (SPC) tools and methods as required Assists qualification of new products/launch activities Prepares appropriate documentation for product inspection, and sample submissions (PPAP, FAI, FMEAs, Control Plans, Check Sheets, Quality Alerts, etc.
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10 years of experience with DoD or other federal agency in Financial Management Financial Management experience includes activities such as monitoring budget execution, preparing financial documentation and reports, preparing trial balances, reconciling accounts, and other accounting functions, budget formulation, completing financial transactions in accounting and financial management systems, auditing, or similar tasks.
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Understanding of general Microbiology laboratory procedures and Skillman campus procedures as related to routing sample management and testing, e.g. Fusion. Understanding of safety, cGMPs and documentation for a Microbiology Laboratory.
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Support product development process through sample management. Participate in business analysis on a weekly basis by preparing samples, picture pack, reports and other documentation using OTB, velocity, and attribute report and color projections for all business needs and contributing/participating to the pre-Monday meeting.
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Review sample and any attached to documentation to assign an identification number and enter information into Laboratory Information Management System (LIMS). This position requires a basic knowledge of computer operation skills to manipulate keyboard while entering sample information into the LIMS. A basic knowledge of food science, chemistry or microbiology is helpful to effectively assign and execute proper test codes and procedures.
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Minimum of 3 years' experience in clinical drug supply management, clinical sample management, and site supply management. Ensure appropriate system documentation is transferred to TMF, with "near real-time" inspection readiness.
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To solve issues that arise during assigned shift and ensure occurrence management documentation and communication with section supervisors and laboratory management. Uses time between sample collections to departmental advantage by filling in with office/clerical work, assisting technical staff, performing general household duties, putting away supplies, checking supplies for current expiration dates, etc.
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The Project Support Administrator I will support Pharma Services projects including but not limited to the following duties: Accessioning specimens received, preparing specimens for laboratory testing, participating in sample data management including performance of quality control checks of data entries, providing reports to study sponsors, transferring data, shipping samples and archiving samples and documentation.
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Contact customers, customer care and off-site leadership when necessary, to obtain and clarify missing or unclear information to ensure that identification of client code, test code, and sample contents are accurate.
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sample management documentation jobs
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