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

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.

• 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.

• 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.

• 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.