The Quality Control Associate – Microbiology is a key part of our growing QC Team and will be primarily responsible for sampling and analysis in support of commercial product development and manufacturing. You will perform internal facility environmental assessments to confirm the facility is under control and within specifications. Coordinate all metrology testing whether performed in house or by a third party.
Essential Duties and Responsibilities
- Works on QC tasks of varied scope, including work related to environmental control and raw materials management
- Demonstrates understanding of QC principles and GMPs.
- Execution of USP/NF or relevant other safety / release assays
- Equipment/instrument standardization and calibration, as required for testing per SOP’s
- Assists in validation/qualification of laboratory methods and manufacturing processes
- Provides input to improving QC systems and procedures to improve GMP.
- Complies with company documentation practices (GDP).
- Reviews and revises specifications for raw material, packaging components, drug products, and reference standards.
- Reviews and revises analytical methods, SOPs, test records, and CofAs
- Supports laboratory investigations related to test failures, discrepancies and deviations.
- Coordinates raw material sampling, inspection, and release as required
- Coordinates sample results received from external laboratories
- Supports maintaining laboratory in inspection readiness state.
- Performs other duties as assigned by management.
- BS or BA in Microbiology or Biological sciences and a minimum of 3-5 years of basic laboratory experience
- Experience and knowledge in the pharmaceutical and/or biotech industry in sampling and testing of critical utilities and environmental monitoring within a GMP and/or GLP environments
- Must have experience with basic microbiological techniques
- Must be able to perform sterlie gowning as required in Production and QC Laboratory areas
- Must be familiar with basic aseptic techniques and requirements
- Knowledge of GMPs, GLPs safety, proper documentation, and data integrity is preferred
- Ability to interact constructively with co-workers
A normal range of hearing and vision correctable to 20/20 is required. Occasional lifting up to 25 pounds is required.