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Microbiologist - II (Associate)

North Durham, NC 27712

Posted: 03/17/2025 Employment Type: Contract Job Category: Scientific Job Number: 618375 Is job remote?: No Country: United States

Job Description


Target Pay Rate: 33-38.77/hr **salary will be commensurate with experience 

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, SOPs 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.

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

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About North Durham, NC

Ready to elevate your career in North Durham, North Carolina? This vibrant area is brimming with job opportunities and endless possibilities for professional growth. Nestled in the heart of the Triangle, North Durham offers easy access to renowned universities, such as Duke University and UNC Chapel Hill, a thriving tech and healthcare sector, and a rich cultural scene including the Durham Performing Arts Center, American Tobacco Campus, and the Durham Bulls Athletic Park. Immerse yourself in the local foodie culture with must-try dishes like Carolina barbecue and visit the Eno River State Park for a peaceful retreat into nature. Explore our job listings today and discover why North Durham is the perfect place to take your career to new heights!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.