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Microbiologist - II (Associate)
5325 Old Oxford Road North Durham, NC 27712 US
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
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The 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, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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