QC Microbiologist

Actalent - Parsippany-Troy Hills, NJ

Full-time - Mid Level

Parsippany-Troy Hills, NJ

Administrative and Support Services

About the position

The QC Microbiologist position at Actalent involves leading compliance-related activities within the Quality Control (QC) laboratory. The role focuses on conducting laboratory investigations, authoring technical protocols, performing data reviews, and ensuring compliance with industry standards. The specialist will also assist management with various compliance tasks and is expected to work in an aseptic manufacturing environment.

Responsibilities

• Perform routine and process environmental monitoring in an aseptic manufacturing environment.
• Conduct sampling and testing of clean utilities (compressed air, Nitrogen, WFI/DIW, and Clean Steam).
• Perform Bioburden, Endotoxin, Total Plate Count, Coliform, Bacteriostatic & Fungi stasis (B&F), Biological Indicator testing, and Plate Reading.
• Write/review material specifications and perform material qualifications (media and reagents).
• Initiate and investigate microbiology-related deviations (NCEs), OOS investigations, and implement appropriate CAPAs as needed.
• Operate Sterility Isolator and perform routine maintenance and testing as needed.
• Perform routine QC responsibilities such as sample coordination, peer review, lab equipment maintenance, QC document management, QC inventory control, and reconciliation of sample requests/documents.
• Monitor laboratory equipment for temperature, humidity, etc., and ensure conformance to specifications.
• Specialize in method development of microbiological methods in one or more disciplines of Microbiology.
• Develop methods for new products/components, author protocols and test methods, execute and troubleshoot findings.
• Act as a subject matter expert in one or more fields of microbiology (e.g., BET, Bioburden Testing, AET, Microbial Identification, Sterility Testing, LIMS).
• Work weekends, overtime, on-call, and holidays as needed.
• Serve as Lead investigator and writer for lab-related issues, conduct formal investigations, and ensure lab investigations are completed within required time schedules.
• Ensure root cause, corrective action, preventative action, and product impact are thoroughly addressed in investigations.
• Develop, implement, manage, and track the effectiveness of corrective action plans for exceptions.
• Participate in Quality Review Board representing the QC Laboratory and communicate status, root cause, and CAPAs.
• Coordinate and lead USP/EP/ICH Committee to assess and trigger change implementation to remain in compliance.
• Assist in the review, approval, and issuance of laboratory documents including SOPs, testing protocols, and new testing methodologies.
• Assist with GMP Compliance program in the QC Laboratory, including management of training records, internal and self-audits, compliance walkthroughs, SOPs and Methods, and deviation reduction initiatives.

Requirements

• Bachelor's Degree in a scientific/technical discipline.
• Minimum of 3 years of industry experience with at least one year in QC Laboratory settings.
• Expertise in performing laboratory investigations, change controls, and associated CAPAs under limited guidance.
• Working knowledge in Labware LIMS configuration of new analyses and product specifications.
• Working knowledge of analytical method development, transfer, and validation methodologies and relevant guidance.
• Knowledge of USP/EP/cGMP and ICH guidelines.
• Familiarity with Laboratory Information Management System (LIMS), Global Quality Tracking System (TrackWise), Microsoft Office, Lean Six Sigma concepts, Lean Labs, project management, formal Quality Change Control, Investigations, and Documentation systems, and Quality Risk Management including risk assessments.

Nice-to-haves

• Experience in microbiology, biology, environmental monitoring, and laboratory plating.
• Expertise in data review and trend analysis.
• Ability to train new hires and act as an SME in one or more disciplines in the area of Microbiology.