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.
Applicant Notices & Disclaimers
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.This position's pay range is $36.00/hr - $39.00/hr.
