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.
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation. 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 starting pay is: $35.00/monthly.
