Description:
Akkodis is seeking a Microbiologist - Laboratory Technician for a 1-year W2 contract position (possible extension of 1 year) with a client located in Ridgefield, NJ. This Laboratory Technician role 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.
Microbiologist - Laboratory Technician job responsibilities include:
- 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, and 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 Laboratory Technicians 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.
- Support all site HSE policies as well as ensure that work performed is compliant with local HSE regulations.
Qualifications:
- Degree in Biology or Microbiology with 6 years of experience in Pharma.
- Exceptional knowledge of USP, EU and ISO regulations a must.
- Experience in validation protocol writing, review, and execution (or over seeing validation execution) - Micro-validation studies.
- Practical experience in general microbiology laboratory techniques working with bacteria, yeast, and mold.
- Working knowledge of cGMPs in pharmaceuticals/biological/aseptic/medical device manufacturing
- Excellent technical writing skills, strong communicator, can work independently, and able to collaborate effectively with personnel and between departments.
- Working knowledge of Word, Excel, and PowerPoint