Quality Control Microbiologist
24 hours ago
Summit
Job Title: QC Associate Scientist, Microbiology Location: Summit, NJ 07901 Assignment Duration: 06 months QC Associate Scientist, Microbiology (Sunday - Wed, 4pm -230am) Pay Range: $ 37-39/hr 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.