Senior Analyst, QC Microbiology

About the role

The Senior Analyst, QC Microbiology at Resilience is responsible for performing and documenting microbiological testing on various samples to ensure GMP compliance. This role involves evaluating data trends, leading investigations, maintaining equipment, and supporting regulatory inspections.

Responsibilities

• Evaluates data trends and authors reports associated with trends.
• Leads and/or participates in investigations involving manufacturing process areas, related to QC processes or data.
• Provides and follows up on ideas for continuous improvements in laboratory processes.
• Maintains and troubleshoots testing equipment.
• Completes required training and trains QC employees in GMP, SHE, QC methods and processes.
• Authors SOPs and serves as a subject matter expert for the EDMS system.
• Troubleshoots methods and processes.
• Supports and/or leads the implementation of compendial changes for raw materials, in-process or finished products tests in accordance with applicable Pharmacopoeias.
• Supports regulatory inspections including potential demonstrations and inspection room discussions.
• Demonstrates expertise on authoring Quality records (Deviations, CAPAs, and Change Controls).
• Answer and guide others in documentation, compliance, and other process questions.
• Gathers, organizes, and communicates operational information to others.
• Serves as a leader, developer, and mentor for others.
• Supports in coordinating activities in the laboratory.
• Identifies temporary and permanent fixes to address issues.
• Collaborates with representatives from other departments.
• Attends team meetings to discuss progress, initiatives, and/or other matters.
• Collects, records, reports and trends metrics when applicable.
• Wears gowning, sterile garments, and PPE (Personal Protective Equipment) as required by specific activities.
• Consults cross-functionally as an SME (Subject Matter Expert) on systems and/or processes within a functional area.
• Performs logbook reviews.
• Leads process improvement activities and teams to meet strategic goals.
• Uses MAXIMO and/or CMMS (Computerized Maintenance Management System) to manage logistics.
• Alerts supervisor or manager when problems occur outside of SOPs (Standard Operating Procedures).
• Performs regular audits of SOPs (Standard Operating Procedures) and/or work instructions.
• Reviews and approves documentation needed for qualification of equipment and processes.
• Attends and facilitates inter-departmental meetings to discuss matters involving the coordination of multiple departments when necessary.
• Interacts with other departments to implement corrective/preventative actions.
• Reviews and approves quality records as a SME when required.
• Provides "off shift" support (i.e., night shift support if you normally work day shift).
• Coordinates qualification activities.
• Aims to improve productivity, waste generation, quality and cost.
• Recommends compliance resolutions to management.

Qualifications

• Prior experience in a regulated GMP environment.
• Working knowledge of cGXP requirements and a strong familiarity with production operations.
• Excellent attention to details and problem-solving skills.

Preferred Qualifications

• Bachelor's degree in a Science subject (Microbiology, or closely related subjects).
• 5 years QC Microbiology laboratory experience.
• High level knowledge and competence with a specific piece of laboratory equipment, or a QC/QA process or system.
• Prior experience supporting microbiological testing in a sterile pharmaceutical operation environment.