Microbiologist in Fair Lawn, NJ at Apex Life Sciences

Date Posted: 2/2/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Fair Lawn, NJ
  • Job Type:
    Science
  • Experience:
    3 to 5 years
  • Date Posted:
    2/2/2018
  • Job ID:
    819308

Job Description


Apex Life Sciences is seeking a Microbiologist to work with our client, a major pharmaceutical company in Fair Lawn, NJ.

The successful candidate will conduct general microbial and/or biological testing of materials and product for in-process or release purposes, in compliance with all applicable procedures and regulations, and ensures assays are transferred, qualified/validated, and performed under cGMP requirements.

Job Description:

  • 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.
  • Performs a variety of duties related to the efficient and effective functioning of a Quality Control lab.
  • Responsibility 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.

QUALIFICATIONS

  • 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.