QC Associate Scientist, Microbiology

Job Title: QC Associate Scientist, Microbiology


Location: Summit, NJ 07901

Assignment Duration: 06 months

QC Associate Scientist, Microbiology 3rd shift (4PM-2:30AM) Sunday-Wednesday

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.