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Ref No.: 18-04549
Location: Fair Lawn, New Jersey
Skill Type
Skill Type:Professional
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.