Job Title
Senior Analyst, Microbiology
Company
National Resilience
Job Description
A career at Resilience is more than just a job – it’s an opportunity to change the future.
Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.
For more information, please visit
Position Summary & Responsibilities
- Execute Environmental Monitoring of classified areas; monitoring of Critical Utilities including WFI collection and Process gasses monitoring; review microbiological and environmental monitoring data.
- Perform BI inoculations and inspections after incubation..
- Conducts enumeration of environmental samples, microbial analysis of water and compressed gasses, Media Fill / APS and AOQ Inspections.
- Trend site Environmental Monitoring (EM) and Critical Utility data and authors quarterly and annual trending reports.
- Perform execution of QC Microbiology test methods – Endotoxin, Bioburden, Growth Promotion, Sterility, Microbial ID (Micro-Seq and MALDI Toff)
- Support new equipment qualification and method validations /suitability for QC Microbiology test methods; Bioburden & Sterility.
- Assist with development, implementation and maintenance of laboratory operational systems in accordance with cGMP requirements
- Perform QC Micro laboratory support activities including equipment maintenance, inventory management (ordering and receiving supplies)
- Support SOPs, protocols creation/revision and Change Control generations.
Minimum Qualifications
- Experience in Environmental Monitoring; strong knowledge of aseptic techniques, Aseptic Process Simulation.
- Experience with data review and conducting investigations
- Experience with leading procedure changes (leading change controls)
- Hands-on experience performing microbiological assays and product release testing.
- Experience with data trending and reports.
Preferred Qualifications
- Bachelor’s Degree in Life Sciences discipline with significant experience in acGMP lab environment or Master’s Degree in Life Sciences discipline with considerable experience in a cGMP lab environment
- Demonstrated knowledge of cGMP/ICH/FDA/EU compliance regulations and USP, EP and JP monographs
- Proficient with MODA and/or NovaTek for issuance of trend reports and experience with the use of LIMS is valuable.
This position may also include the following conditions:
- Ability to efficiently and independently prioritize; manage and complete multiple projects and tasks in fast-paced environment
- Ability to collaborate effectively in a dynamic, cross-functional environment
- Excellent communications skills both verbal and written
The items described here are representative of those that must be met successfully to perform the essential functions of this job.
Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.
Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $70,000.00 – $107,500.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.
Expected Salary
$70000 – 107500 per year
Location
Alachua, FL
Job Posting Date
Fri, 01 Dec 2023 08:10:01 GMT