QC Associate Scientist, Microbiology

Job Title: QC Associate Scientist, Microbiology Location: Summit, NJ 07901 Assignment Duration: 06 months QC Associate Scientist, Microbiology (Sunday - Wed, 4pm -230am) 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/RESPONSIBILITIES * Carry out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws. * Ensure compliance with current Good Manufacturing Procedures (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 come up in the day to day operation 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 Environmental Monitoring on routine basis. * Perform microbial isolation techniques and perform Gram stain identifications. * Send out samples to contract labs and track results/reports. * Evaluate environmental/personnel monitoring samples and create NOEs for action levels. * Performs general laboratory cleaning/wipe-down. * Perform routine maintenance of lab equipments. * Under the guidance of management, support special project work. * Document laboratory test results on worksheets, forms and logbooks utilizing Good Documentation Practices. * Maintain lab inventory and order lab supplies and materials. * Receives and stock test reagents, lab supplies and test media. * Support continuous improvement projects related to QC * Author and revise controlled documents such as Standard Operating Procedures and Controlled Forms. Author non-routine Protocols/Validation Plans/ 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/EXPERIENCE REQUIREMENTS * Requires Bachelor's degree in Microbiology, Molecular Biology, or related discipline and minimum 3 years of experience working in a regulated manufacturing environment. Microbiology lab experience & Master's Degree strongly preferred. An equivalent combination of experience/education is acceptable. * Have a good understanding of USP, EP, JP, and FDA microbiology testing requirements. * Good knowledge of Microsoft Word and Excel. * Responds to challenges and additional projects in an understanding, positive, and objective manner. * Adaptable to dynamic conditions, work practices, and project timelines. * Ability to multitask, prioritize workload and interpret data accurately. * Able to communicate effectively with GDPO functional areas and external agencies. * Fosters teamwork and promotes an environment that motivates others to achieve our goals. Working Conditions * The incumbent will be required to wear uniform/ PPE to work in the manufacturing or laboratory environment. * The incumbent may be required to stand and walk for extended amount of time. * The incumbent may be required to work hazardous materials. * Flexibility with schedule (weekends, holidays, extended hours and rotating/staggered shift) is an absolute must. * Change to work timings and assigned tasks may occur at a very short notice to support business needs. * Shift schedule could include 4 days including weekends.