Healthcare Analyst Jobs in New Jersey

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.
- Perform 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.
- Receive 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.

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.