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Job Details

The QC Microbiologist will focus on Quality Control microbiological testing at AHP and work closely with other departments within the Quality Unit to ensure drug product meets all standards.

This job is compliance critical and responsibilities include ensuring continual and proper compliance with all division, corporate, and government regulatory requirements

PRIMARY DUTIES AND RESPONSIBILITIES: 

• Ensure Quality Control activities are compliant with FDA, DEA, other regulatory body requirements as applicable.  Ensure compliance with local and corporate policies and procedures. 

• Perform microbiological testing for drug products in accordance with compendial and global requirements, as applicable. 

• Perform environmental monitoring sampling and testing for controlled manufacturing areas. 

• Develop, revise, and review standard operating procedures (SOPs), work instructions (WIs), and test method documents to ensure compliance with applicable compendia and regulations.  

• Assist in the support of manufacturing operations including process validation, environmental monitoring, and utilities as applicable. 

• Perform review and release of microbial tests for compliance to SOPs and regulatory requirements and ensure data is reported accurately. 

• Prepare lab reports as required. 

• Assist with root cause investigations for quality incidents related to microbiology or environmental monitoring. 

• Maintain Quality System records and ensure completeness and accuracy. 

• Coordinate with department management to identify and implement compliant process improvements. 

• Clarify regulations, policies, and procedures to internal teams as applicable. 

• Coordinates with departmental leaders to develop appropriate corrective actions resulting from investigations, internal audits, and facility inspections. 

• Conduct follow-up checks on the effectiveness of corrective actions 

• Performs other duties to support Quality Systems and Regulatory Affairs department as assigned. 

EXPERIENCE AND EDUCATIONAL REQUIREMENTS: 

Bachelor’s degree in microbiology or biological sciences required.  Three or more years’ experience within a pharmaceutical manufacturing (cGMP) laboratory environment.  Should have a working knowledge of pharmaceutical manufacturing requirements, Quality System principles (Documentation, Training, Investigations/CAPA, Change Control, etc), and global Quality Control regulations. 

Experience with MasterControl or other electronic quality management system