Looking for someone with the following expertise:
• 100% proficient in microbiology lab skills and quality control background.
• Testing microbiology methods.
• GMP systems.
• Strong technical expertise with authoring quality and change control documents is a must.
• Data reviews.
• Technical assessment.
• Updating SOP's.
• GLIMS/LIMS.
Qualifications: No PHD or Associate degree.
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.
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