QC Associate Scientist, Microbiology - Wed-Sat

QC Associate Scientist, Microbiology – Summit, NJ 07901 – 6 month assignment

This position works independently and with the team to perform routine and non‑routine microbiological testing, laboratory maintenance, and environmental monitoring.

• Carry out responsibilities in accordance with the organization’s policies, procedures, and applicable laws.
• Ensure compliance with current Good Manufacturing Practices, USP, EU, and other global regulatory requirements.
• Follow directions, work cooperatively as an individual contributor and team member.
• Communicate effectively with QC peers, cross‑functional peers, and management.
• Assist in troubleshooting and problem solving in day‑to‑day operations.
• Participate in aseptic process qualifications, including gowning and media fill reads.
• Perform Bacterial Endotoxin and Sterility Testing.
• Perform microbial identification via PCR.
• Perform growth promotion testing of microbiological media.
• Perform mycoplasma testing via PCR.
• Perform Environmental Monitoring on a routine basis.
• Perform microbial isolation techniques and Gram stain identifications.
• Send samples to contract labs and track results and reports.
• Evaluate environmental/personnel monitoring samples and create NOEs for action levels.
• Perform general laboratory cleaning/wipe‑down.
• Perform routine maintenance of lab 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 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 and forms; author non‑routine protocols, validation plans, and reports.
• Assist with investigations and CAPAs associated with microbiological testing.
• Support data trending and tracking of results.
• Perform all other duties as assigned.

• Bachelor’s degree in Microbiology, Molecular Biology, or related discipline (Master’s preferred); 3+ years in a regulated manufacturing environment.
• Strong microbiology lab experience; equivalent education/experience accepted.
• Good understanding of USP, EP, JP, and FDA microbiology testing requirements.
• Proficient with Microsoft Word and Excel.
• Positive attitude, adaptable, and good at multitasking, prioritizing, and interpreting data accurately.
• Effective communicator with GDPO functional areas and external agencies.
• Team player who fosters teamwork and motivates others.

• Uniform/ PPE required in manufacturing or laboratory environment.
• May be required to stand, walk for extended periods, and work with hazardous materials.
• Flexibility with schedule (weekends, holidays, extended hours, rotating/staggered shifts) is mandatory; shift may include 4 days including weekends.
• Change to work timings and tasks may occur on short notice to support business needs.