The Micro QC Scientist II 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 shoot
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 requiredConveys complex information in a concise mannerMotivate and Develop teamsInteract with Project Teams and cross-functional groups related to site operationsAnalyst Qualifications :
The Senior Microbiologist is expected to act on and demonstrate the
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 acrossthe 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.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 alland 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 5-6 years' experience is required.A thorough understanding of validation testing; write, execute and report validation studiesPractical 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 manufacturingExcellent technical writing skillsAbility to collaborate effectively with personnel and between departmentsStrong analytical and problem-solving skillsMake sound judgement from dataPro-ActiveStrong communicatorWorks independentlyWorking knowledge of Word, Excel and PowerPointPreferred experience with a deviation / CAPA enterprise system
