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Ref No.: 18-01634
Location: Fair Lawn, New Jersey
The position requires the utmost attention to detail, very strong organizational skills, computer proficiency, and a basic understanding of microbiology and laboratory instrumentation. In addition, effective communication skills and the ability to function in a fast-paced, highly technical environment with minimal supervision are essential for success.

Conducts general microbial and/or biological testing of materials and product for in-process or release purposes, in compliance with all applicable procedures and regulations. Ensures assays are transferred, qualified/validated, and performed under cGMP requirements. Performs a variety of duties related to the efficient and effective functioning of a Quality Control lab.


Analysis platforms include: PCR, qPCR, culture and microbiological assay
The successful candidate will be responsible for performing routine environmental monitoring, product testing, and raw material testing.
Performs bioburden and endotoxin testing of raw materials, in-process samples and finished products
Perform Microbial Limits testing, DNAS, RNAS, Protease testing on Finish product and Bulk raw material
Reports any non-conformances. Initiates and/or leads resolution efforts and laboratory investigations.
Prepares environmental excursion reports and conducts laboratory investigations.
Maintain a clean and safe working environment; adhere to existing safety protocols and participate in department safety programs
Report results through the LIMS system and maintain good recordkeeping.
Partner with internal and external customers to assist in problem solving
Executes the qualification / validation of microbiological assays.
Responsible for routine laboratory upkeep and organization
Maintains laboratory supplies, media and reagents inventory for QC laboratory.
Adheres to standard operating procedures and good documentation practices to ensure data integrity and traceability.
The ideal candidate is self driven and task oriented, and is allowed to work in their own time but will have to meet deadlines.
Complies with all applicable company, site and client policies and procedures.
Assist in reviews, modifies SOPs and other lab documents as necessary.
Performs preventative maintenance and calibration activities on QC instrumentation
Knowledge of Analytical instrument and /or analytical testing is preferred.

Bachelor's degree with 3-5 years relevant laboratory experience or experience in a cGMP/FDA regulated industry. Degree in Microbiology, Biology, Molecular Biology, Biochemistry
Ability to work independently or as a team member.
Demonstrated knowledge in Microbiology and aseptic techniques preferred.
Detail-oriented with strong written and verbal communication skills.
Ability to problem-solve and troubleshoot as necessary.