Edison-New Brunswick Metro Area, NJ
Associate, QC Microbiology
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 and procedure.
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.
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 GDP.
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.
Requires Bachelor s degree in Microbiology, Molecular Biology, or related discipline and minimum 2 years of experience working in a regulated manufacturing environment. An equivalent combination of experience/education is acceptable.
Have a good understanding of USP, EP, JP, and FDA microbiology testing requirements.
Change to work timings and assigned tasks may occur at a very short notice to support business needs.
Shift schedule could include 4 10 hour days including weekends.
**Must have flexibility 2 shifts Wed - Sat or Sunday to Wed 10 hours
6 am to 4 pm or 1 pm 10 pm