Junior Team Member - Microbiology

Overview

The role involves performing microbiological analysis on assigned samples to verify compliance with quality standards and specifications. Precise execution and accurate reporting are crucial to ensure timely sample release within agreed timelines.

Primary Responsibilities

• Conduct sample analysis based on priority and allocation, adhering to microbiological protocols.
• Assess data against defined specifications and document outcomes meticulously.
• Submit detailed reports to the team leader promptly to maintain service level agreements (SLAs).
• Report any deviations, procedural non-compliances, equipment malfunctions, or abnormal observations immediately for corrective measures.
• Initiate investigations into irregularities or lab errors on a priority basis to prevent recurrence and enable timely batch release.
• Maintain thorough documentation of raw data and findings to support quality assurance reviews and comply with GLP standards.
• Ensure that all work is performed in accordance with SOPs, cGMP, and GDP guidelines to avoid regulatory issues.
• Monitor and upkeep laboratory instruments and equipment to prevent malfunctions and maintain operational integrity.

Challenges

• Accessing validation records from other sites can create difficulties in analysis processes.
• Coordinating resources and materials among multiple lab units under conflicting priorities to meet SLA requirements.

Interactions

Internal: Frequent engagement with various units for document and specification receipt, regular coordination with QA/QC for product sample releases, and communication with stores for procurement needs.

External: Liaison with CQA for obtaining pharmacopeial guidelines as required.

Workload & Metrics

• Review and release around 15 microbiological lab test (MLT) reports daily.
• Manage approximately 15 sterility batches and 15 bioburden samples each week.
• Analyze and release about 50 water samples.
• Prepare and handle 10 Technical Information Sheets for swab tests.
• Oversee 6 autoclave and dry heat sterilizer operations.
• Release environmental monitoring data from approximately 200 locations daily.

Decision-Making

Recommend daily media and plate requirements to the Microbiology Team Leader.

Qualifications & Experience

• Master's degree in Microbiology.
• 1 to 5 years of experience as an analyst, or 3 to 7 years as a reviewer in microbiology roles.
• Proficient knowledge in microbiology techniques, strong task execution skills, and good command of English communication.