Overview

The Quality Control Microbiology Associate II serves as a support role to clinical and commercial production at the Allendale, NJ facility. The QC EM Associate will provide environmental monitoring data to ensure that quality standards are upheld for all products produced at the facility.

Duties and responsibilities:

Under the direction of the Manager, QC Microbiology, responsibilities of the QC Microbiology Associate II will include but are not limited to:

Environmental monitoring in controlled environments:

o Non-viable particulate monitoring using Met One and Climet equipment

o Active viable air monitoring using SAS equipment

o Personnel monitoring

o Surface sampling

o Passive air monitoring

· Equipment monitoring:

o Ensure equipment is in proper working conditions

o Ensure all equipment is properly maintained/calibrated

o Program equipment with proper workflows

· Assist with routine laboratory testing:

o Plate reads and incubations

o Growth Promotion

o Microbial Identifications

· Shipping of test samples and equipment to contract laboratories for testing

· Documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).

· Writing/conducting investigations pertaining to environmental monitoring and testing

· Assist in the creation/revision to Standard Operating Procedures, Work Instructions, Forms, and Protocols

Qualifications include:

· BA/BS in a science

· Biotechnology Certificate and/or cGMP experience

· Minimum 6 years of experience in environmental monitoring within the biopharmaceutical industry

· Candidate must be familiar with ISO and EU classified environments

· Proficient with computer software such as

o Microsoft Office

o MODA

o Visio

· Strong written and oral communication skills

· Candidate must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilities