Quality Control Microbiologist

Job Title: QC Associate Scientist, Microbiology

Location: Summit, NJ 07901

Assignment Duration: 06 months

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

• For information on benefits, equal opportunity employment, and location-specific applicant notices, click here

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.