QC Associate Scientist, Microbiology

QC Associate Scientist, Microbiology Location: Summit, NJ 07901 Assignment Duration: 6 months Shift: Wednesday‑Saturday 1st Shift 8am to 6:30pm Position Summary This position will work both independently and with the team to perform routine and non‑routine microbiological testing, microbiology laboratory maintenance functions and environmental monitoring functions where necessary. Primary Duties and Responsibilities Carry out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws. Ensure compliance with current Good Manufacturing Practices (cGMP), USP, EU and other global regulatory requirements at all times. Follow directions properly, work cooperatively as an individual contributor and as a team member. Communicate effectively with QC peers, cross‑functional peers and management. Assist in troubleshooting and solving problems that may arise in day‑to‑day operations of the department. Participate in aseptic process qualifications, such as aseptic gowning and media fill reads. Perform Bacterial Endotoxin and Sterility Testing. Perform microbial identification via polymerase chain reaction (PCR). Perform growth‑promotion testing of microbiological media. Perform mycoplasma testing via PCR. Perform routine Environmental Monitoring. Perform microbial isolation techniques and Gram‑stain identifications. Send out samples to contract laboratories and track results/reports. Evaluate environmental/personnel monitoring samples and create NOEs for action levels. Perform general laboratory cleaning / wipe‑down. Perform routine maintenance of laboratory equipment. Support special project work under management guidance. Document laboratory test results on worksheets, forms, and logbooks using Good Documentation Practices. Maintain lab inventory and order lab supplies and materials. Receive and stock test reagents, lab supplies and test media. Support continuous improvement projects related to QC. Author and revise controlled documents such as SOPs, controlled forms, non‑routine protocols, validation plans, and reports in support of projects. Assist with investigations & CAPAs associated with microbiological testing. Support data trending and tracking of results. Perform all other duties as assigned. Education and Experience Requirements Requires a Bachelor's degree in Microbiology, Molecular Biology, or a related discipline and a minimum of 3 years of experience in a regulated manufacturing environment. Microbiology lab experience and a Master’s degree preferred; equivalent combination of experience and education is acceptable. Good understanding of USP, EP, JP, and FDA microbiology testing requirements. Good knowledge of Microsoft Word and Excel. Demonstrates the ability to respond to challenges and additional projects with a positive, objective attitude. Adaptable to dynamic conditions, work practices, and project timelines. Shows ability to multitask, prioritize workload, and interpret data accurately. Communicates effectively with GDPO functional areas and external agencies. Fosters teamwork and promotes a motivating environment that helps achieve goals. Working Conditions Incumbent will be required to wear uniform / PPE while working in the manufacturing or laboratory environment. Incumbent may be required to stand and walk for extended periods. Incumbent may be required to work with hazardous materials. Flexibility with scheduling (weekends, holidays, extended hours, rotating or staggered shifts) is essential. Work timings and assignments may change on short notice to support business needs. Shift schedule may include four days, including weekends. #J-18808-Ljbffr Spectraforce Technologies