Quality Control Analyst

Job Title: QC Micro Analyst Location: Summit, NJ 07901 Assignment Duration: 06 months 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. Perform general laboratory cleaning/wipe‑down. Perform routine maintenance of lab equipment. 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. Receive 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. #J-18808-Ljbffr