Lead Associate 1, Quality Control Microbiology (Sun to Wed 7am to 5pm)

Lead Associate 1, Quality Control Microbiology (Sun to Wed 7am to 5pm)

The Lead Associate 1, Quality Control (QC) Microbiology oversees and guides the critical operational functions of the QC Microbiology laboratory. This position holds the responsibility for conducting microbiological assays, as well as effectively training junior analysts in these areas. The role is pivotal in guaranteeing "right the first time" execution to support timely batch disposition of manufacturing goods. Additionally, this role ensures technical issues are promptly escalated to laboratory management and upholds high standards of accuracy and efficiency within the laboratory operations.

Job Description

The Lead Associate 1, Quality Control (QC) Microbiology oversees and guides the critical operational functions of the QC Microbiology laboratory. This position holds the responsibility for conducting microbiological assays, as well as effectively training junior analysts in these areas. The role is pivotal in guaranteeing "right the first time" execution to support timely batch disposition of manufacturing goods. Additionally, this role ensures technical issues are promptly escalated to laboratory management and upholds high standards of accuracy and efficiency within the laboratory operations.

Responsibilities

• Performs complex microbiological testing (e.g., Bioburden, Endotoxin, Culture Purity, and Microbial Identifications) per department Standard Operating Procedures (SOPs) and test methods for samples associated manufactured batches.
• Reviews technical data, authors routine and periodic laboratory reports (e.g., Environmental Monitoring (EM) trend reports) and contributes to technical documentation and assessments.
• Supports client audits and regulatory inspections as an assay or method Subject Matter Expert (SME), as needed.
• Ensures laboratory maintains inspection readiness, data integrity, and Current Good Manufacturing Practice (CGMP) compliance.
• Partners with management for technical services, such as initiating events (e.g., deviations and non-conformances) within quality systems.
• Leads laboratory deviations and investigations.
• Identifies and solves problems while informing and consulting with management.
• Participates in project developments from concept through execution, ensuring alignment with organizational goals.
• Partners with laboratory management to schedule daily, weekly, and non-routine testing and tasks.
• Provides technical guidance and mentorship to junior associates.
• Participates in laboratory equipment qualification and validation activities.
• Troubleshoots laboratory equipment, assay and method issues with the support of laboratory management.
• As a highly skilled specialist, contributes to the development of concepts and techniques. Completes complex tasks in creative and effective ways.
• Acts independently to determine methods and procedures on new assignments. Often acts as a facilitator and team leader.
• Consistently works on complex assignments requiring independent action and a high degree of initiative to resolve issues. Makes recommendations for new procedures.
• Performs other duties, as assigned.

Requirements

Preferred Experience

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