Microbiology Project Lead — GMP & Laboratory Excellence

Allergan; Waco (TX); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie in the United States is seeking a Microbiology Department Project Lead to serve as the technical leader for a sterile pharmaceutical manufacturing site. You will oversee microbiological testing, environmental monitoring, contamination control, and GMP documentation while coordinating cross-functional teams.

This role drives method qualification, change controls, investigations, CAPAs, and quality system improvements, partnering with QA, Manufacturing, Engineering, Validation, and

Qualifications

• Bachelor’s degree in Science/Engineering/Business Management or equivalent technical work experience.
• 5+ years of relevant Quality experience in GMP pharmaceutical/biologics/medical device manufacturing.
• Strong understanding of cGxPs, regulatory inspections, regulatory documents and global regulations.
• Experience in Project Management and leading cross-functional teams with technical professionals.
• Strong communication, time management, influence and problem-solving skills.
• Proficient in standard software applications including Office 365.

Responsibilities

• Serve as the technical lead for the Microbiology department, providing oversight for testing, monitoring, contamination control and lab operations.
• Lead and manage microbiology-related projects from initiation through implementation.
• Own and coordinate microbiology change controls and ensure timely closure of quality records.
• Author, review, approve, and implement microbiology procedures to maintain GMP compliance.
• Lead method qualification, verification, validation and transfer activities for microbiological methods.
• Provide technical review of investigations, deviations, CAPAs related to microbiology.
• Partner with QA, Manufacturing, Engineering, Validation and Regulatory Affairs to support changes and improvements.
• Assess microbiological risks and drive continuous improvement for lab efficiency and data integrity.
• Monitor regulatory expectations and support inspections and audits as SME.

Skills

GMP compliance

Quality systems

Microbiology

Project management

Regulatory inspections

Cross-functional collaboration

Office 365

Education

Bachelor’s degree in Science/Engineering/Business Management

Tools

Office 365

Job description

AbbVie in the United States is seeking a Microbiology Department Project Lead to serve as the technical leader for a sterile pharmaceutical manufacturing site. You will oversee microbiological testing, environmental monitoring, contamination control, and GMP documentation while coordinating cross-functional teams.

This role drives method qualification, change controls, investigations, CAPAs, and quality system improvements, partnering with QA, Manufacturing, Engineering, Validation, and