Quality Control Analyst

Job Title: QC Micro Analyst
Location: Summit, NJ 07901
Assignment Duration: 06 months
QC Micro Analyst (Wed-Sat 6:30 AM - 4:30 PM)

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.