Microbiology - Snr Research Associate
Edison-New Brunswick Metro Area, NJ
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 on in- process, stability and finished drug products.
Perform microbial identification via polymerase chain reaction (PCR).
Perform growth promotion testing of microbiological media.
Perform mycoplasma testing via PCR.
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 and forms 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 in support of projects.
Assist with deviation, Investigations/CAPA s associated with Microbiological testing.
Support data trending and tracking of results.
Perform other duties as assigned.
EDUCATION / EXPERIENCE REQUIREMENTS:
Requires Bachelor s degree in Microbiology, Biotechnology, Molecular Biology, or related discipline and minimum 5 years of experience working in a regulated manufacturing environment. Microbiology lab experience strongly preferred. An equivalent combination of experience/education is acceptable.
Have a good understanding of USP, EP, JP, and FDA microbiology testing requirements.
Understanding of and ability to apply the regulations associated with 21 CFR 210/211.
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.
Provide schedule flexibility when needed.
Ability to multitask, priortize 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.
The incumbent will be required to wear uniform/ PPE to work in the manufacturing or
The incumbent may be required to stand and walk for extended amount of time.
The incumbent may be required to work hazardous materials.