Military Spouse Connection Jobs

Nature and Scope As part of Research and Development Operations, the R&D Sample Coordinator is primarily responsible to provide support for the stability program, including, the proper receipt and distribution of samples and the assurance that contract testing is completed on schedule.Also included in the stability program support is the issuance of needed worksheets and complete stability folders. The R&D Sample coordinator will also be responsible for coordinating outside vendor testing for products in the pipeline. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Coordinate sample delivery and receipt activities with Production Operations, any American Regent site, or any 3rd party CMO. Responsible to ensure that all finished product samples received by the R&D Group are, upon receipt, properly handled, logged, and stored. Responsible for staging all products to start their specific stability programs as per the respective protocols. Responsible to ensure that all raw material and/or finished products are promptly distributed to the appropriate laboratories and contract labs for outside testing. Maintain continuous and direct contact with contract lab representatives, thus assuring that all deadlines are met, and reports are received in a timely manner. This also includes the distribution of data to associated personnel. Responsible to ensure that all relevant contracts are compiled in accordance with procedures and request PO numbers from the Accounting Department when necessary. Responsible for timely follow up with all contracts PO numbers for outside testing. Responsible for the reference standard lifecycle, including purchase, receipt, distribution, and reconciliation of reference standards. Store samples in accordance with material requirements and dispose them according to company policy and SOPs. Responsible to maintain a current inventory of the stability chambers and to maintain the life cycle of all finished products currently in the stability chambers. Responsible for maintaining a finished product sample lifecycle for all products actively on an R&D Exhibit Batch Stability Program. Responsible for maintaining inventory of the Reference Listed Drugs (RLD) used in the laboratory and is responsible for working with the Formulation Leads on disposition of the RLDs currently being used in the laboratory, as well as managing any expired RLDs. Responsible to issue and reconcile analytical work sheets. Responsible to create folders with appropriate sample request forms, stability testing summary forms, and worksheets. Responsible to file all reconciled folders and maintain the organization of the CMC document room as to ensure the prompt retrieval of documents when necessary. Package and ship out samples for outside testing or to other departments as needed. Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. High School diploma or GED required. Associate's Degree or equivalent preferred. Minimum 2 years of experience in a laboratory or pharmaceutical setting preferred. Well-organized, detail oriented, and has good documentation practices. Must be able to work independently, recognizing what needs to be done and accomplishing it with minimal supervision. Motivated self-starter. Is able to problem solve, think critically, and able to provide feedback and input to arrive at mutually beneficial solutions. Must be able to champion new ideas and follow through until implementation. Adhere to scheduled timelines while maintaining