Description
The Quality Control Microbiology Specialist supports Quality Control laboratory operations by providing technical, documentation, investigation, and project support to ensure compliant, efficient, and reliable laboratory performance.
Key Responsibilities:
- Writes, updates, reviews, and maintains Laboratory Standard Operating Procedures, Analytical Methods, Specifications, and related controlled documents in alignment with current Good Manufacturing Practice (GMP), regulatory, and site requirements.
- Serves as lead investigator for QC-related Deviations, Laboratory Investigation Reports, Change Controls, and Corrective/Preventive Actions, ensuring timely, scientifically sound, and compliant record closure.
- Provides technical and quality support for laboratory operations, including data review, documentation practices, assay/process troubleshooting, and inspection readiness activities.
- Supports initiatives to improve Quality Operations, laboratory efficiency, schedule adherence, right-first-time performance, and overall GMP performance.
- Leads continuous improvement and problem-solving activities for the QC team using appropriate tools to identify root causes, reduce waste, improve process robustness, and sustain improvements.
- Represents the QC team on site-based projects and cross-functional activities, including maintenance, shutdowns, non-routine work, laboratory readiness, and implementation planning.
- Partners with quality assurance (QA), Manufacturing, Engineering, Validation, MSAT, Supply Chain, and other stakeholders to assess quality impact, resolve issues, and implement sustainable actions.
- Supports internal and external audit/inspection readiness by preparing documentation, providing SME input, responding to requests, and supporting execution of commitments.
- Provides guidance, coaching, and training to laboratory staff on procedures, documentation expectations, investigations, quality systems, and continuous improvement practices.
- Maintains awareness of applicable GMP, regulatory, safety, and site requirements and ensures assigned activities are performed in a compliant and safe manner.
Basic Qualifications:
- Bachelor’s Degree in Biochemistry, Chemistry, Biology, Microbiology, Pharmaceutical Sciences, or related technical discipline or related experience
- 3+ years of experience in a Good Manufacturing Practice/ Good Practice (GMP/GxP) regulated laboratory, quality, manufacturing, or technical operations environment; experience with laboratory investigations, controlled documents, quality systems, and continuous improvement is preferred.
Preferred Qualifications:
- Master’s Degree Scientific, technical, quality, or laboratory-related discipline
- Demonstrated leadership, ownership, and accountability for quality, technical, and operational deliverables.
- Strong written and verbal communication skills, including the ability to produce clear, compliant, audit-ready documentation.
- Effective problem-solving skills and ability to lead root cause analysis, Corrective and Preventive Action (CAPA) development, and continuous improvement activities.
- Able to prioritize, manage timelines, make risk-based decisions, and implement actions in a complex, fast-paced environment.
- Able to influence without authority and collaborate effectively across QC, QA, Manufacturing, Engineering, Validation, Manufacturing Science and Technology (MSAT), Supply Chain, and site support functions.
- Solid team player able to work independently while supporting team-based laboratory operations and site priorities.
- Knowledge of GMP, International Council for Harmonisation (ICH), Food and Drug Administration (FDA), and other applicable regulatory expectations for laboratory operations, analytical documentation, investigations, and quality systems.
Work Arrangements: This is a predominantly on-site role. Limited remote work flexibility may be available, typically up to 1-2 days per week, subject to business needs and manager.