New 
Associate Microbiologist
 Spectraforce Technologies | |
 United States, North Carolina, Durham | |
| 5325 Old Oxford Road (Show on map) | |
 Mar 13, 2025 | |
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Associate Microbiologist
8 months Durham, NC 27712 Qualifications: Education Minimum Requirement: * B.S. degree in a science field required, preferably biology, microbiology, or biological sciences. (Microbiology preferred) * M.S degree in a science field required, preferably biology, microbiology, or biological sciences. (Microbiology preferred) Required Experience and Skills: * Good technical writing skills and high attention to detail. * Three to Five years (3-5) years in GMP laboratory within pharmaceutical industry. * Work independently and within a team environment. * Good communication and strong organization skills * Familiarity with Change Management/ Change Controls * Familiarity with LIMS systems. Preferred Experience and Skills: * Knowledge of cGMP and cGDP. * Strong technical document authoring skillset. * Experience in writing Protocols, SOP, Reports, and other technical documents. * Strong computer, scientific, and organizational skills. * Project Management Skills * Knowledge of Change control process * Knowledge of Compendia microbiological testing methods * Experience in microbiology assays including Bioburden, Endotoxin and Sterility testing. * Understanding of analytical method transfers. * System familiarity: Veeva Vault, IPI, LIMS. Personality: * Strong communication * Collaborative * Proactive * Team Player Responsibilities: Job Description:- Large Molecule Analytical Sciences-Durham * The Contractor in Analytical Sciences will join a technical team to provide support to Quality Control labs, focusing on microbiology, particularly in Bioburden, Endotoxin, and Sterility methods during analytical method transfers. * The successful candidate will work on authoring technical documents, change controls, project management support, technical problem solving and support other GMP laboratory readiness for variety of products. * The successful candidate will also be expected to review and authorize testing results, provide project management support, have a strong understanding of Labware Laboratory Information Management System (LIMS), and Change Control process. Primary Responsibilities: Large Molecule Analytical Sciences responsibilities include but not limited to, the following: * Function as part of Durham Analytical Sciences team. Has knowledge of standard microbiological testing and laboratory experience. * Perform data review of laboratory test data and associated records. * Author Protocols, SOP's and Reports as needed. * Authorize results in LIMS as needed. * Support key projects for Laboratory Operations aimed at elevating compliance, assay robustness, and performance of the laboratories within their responsibility. * Potential support required in technical oversight of laboratory microbiology assays. * Potential support in providing analytical change management support for QC lab. * Initiates and contributes to laboratory investigations as needed and follows site procedures in the documentation of Quality Notifications and Preventative Actions * Collaborate with Durham Laboratory Compliance to ensure adherence to regulatory requirements. * Supports our Company's Manufacturing Division (MD) divisional and Quality initiatives. | |