Quality Control Microbiology Specialist

Job Title:

Quality Control Microbiology Specialist

Job Purpose:

The QC Specialist supports Quality Control laboratory operations by providing technical, documentation, investigation, and project support to ensure compliant, efficient, and reliable laboratory performance. This role writes, updates, and reviews laboratory procedures and technical documents; leads quality investigations and corrective/preventive actions; supports Quality Operations and GMP performance initiatives; drives continuous improvement and problem-solving activities; and represents the QC team on site-based projects, shutdowns, maintenance activities, and other non-routine work.

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 (Quality Control) 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 experience3+ 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.

The incumbent is responsible for adhering to all applicable safety, quality, data integrity, and documentation requirements.

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…