The Senior Microbiologist is dedicated to the Microbiology Laboratory and microbiology studies. The role of the Senior Microbiologist will be that of a Subject Matter Expert for any lab or EM as related to Microbiology, Testing, Aseptic Practices, Environmental Monitoring for Controlled Facilitates. The candidate will review, author and execute Micro-validation studies. The Candidate will mentor and educate the junior Analysts on matters directly related to lab operation and testing.
The Senior Microbiologist is part of the Quality Assurance Department at Ridgefield, NJ. This role is responsible for providing direction, mentoring and completing high level projects for the Micro team. This position also includes product testing, release EM Monitoring, data review and validation.
HOURS:
Monday - Friday from 8:00 am to 4:30 pm. Some flex in the start and end times may be allowed; weekend work and overtime as required.
• Exceptional knowledge of USP, EU and ISO regulations a must.
• The candidate must have previous quality control microbiology experience in bioburden testing, membrane filtration, sterility isolator testing, conductivity, total organic carbon, endotoxin assays
• Basic knowledge of aseptic manufacturing environmental monitoring of Grade A-D Areas.
• Validation protocol writing, review and execution (or over seeing validation execution)
• SOP review, creation and approval
• OOS investigations writing/review and approval.
• Mentor junior Analysts on testing, trouble shooting and Lab related items
• Ensure compliance with all cGMP standards, safety and environmental regulations and company SOPs.
• Provide advice to subordinates based on general policies and management guidance.
• Ensure that high level projects are completed on schedule and accurately.
• Data review of EM sampling, LIMS, logbooks, and other miscellaneous lab data.
• Participates in Change Control meetings as the Microbiology Subject Matter Expert and initiates change controls as required.
• Support regulatory, third party and internal audits when required
• Conveys complex information in a concise manner
• Motivate and Develop teams
• Interact with Project Teams and cross-functional groups related to site operations
nalyst Qualifications:
The Senior Microbiologist is expected to act on and demonstrate the Client LEAD competencies:
• Act for Change: Embrace change and innovation and initiate new and improved ways of working.
• Cooperate transversally: Collaborate effectively with peers, stakeholders and partners across
the organization to positively impact business results.
• Develop People: Take responsibility for developing one's self and mentor other Micro Personnel in anticipation of future business needs or to assist the micro department.
HSE
• It is required that individuals care for their own safety and wellbeing. Individuals must promote a safe working environment for employees and contractors working in their area of responsibility.
• The individual must support all Client and site HSE policies as well as ensure that work performed is compliant with local HSE regulations.
• Individuals must complete all required HSE trainings. Everyone is required to report all accidents and incidents and support investigations in their areas of responsibility. Individuals must ensure timely closure of HSE actions owned by their departments.
Physical Requirements include the capacity to lift and carry up to 20 pounds, kneel, reach and stretch, and to stand for at least 4 hours.
BA/BS in Microbiology/Biology with 6-10 years experience is required.
thorough understanding of validation testing; write, execute and report validation studies
Practical experience in general microbiology laboratory techniques working with bacteria, yeast and mold.
Prior experience with, writing protocols, data review, authoring SOPS, Change Controls, out of specification investigations and report writing.
Working knowledge of cGMPs in pharmaceuticals/biological/aseptic/medical device manufacturing
Excellent technical writing skills
bility to collaborate effectively with personnel and between departments
Strong analytical and problem-solving skills
Make sound judgement from data
Strong communicator
Works independently
Working knowledge of Word, Excel and PowerPoint
Preferred experience with a deviation/CAPA enterprise system