Analyst, Microbiology (Contract)

SUN PHARMA; Brampton; On-site; CAD 55,000 - 85,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking a Microbiologist to perform critical microbiological testing and ensure compliance with GMP requirements. The role entails conducting various tests, maintaining equipment, and documenting results, all while working within a collaborative laboratory environment. Ideal candidates should hold a B.Sc. or M.Sc. in Microbiology and possess relevant laboratory experience and strong analytical skills.

Qualifications

• Minimum 1-3 years of experience in a pharmaceutical microbiology laboratory preferred.
• Ability to apply knowledge of microbiology, math, instrumentation, and statistics.
• Thorough understanding of GMPs.

Responsibilities

• Conduct microbiological testing as per USP for various samples.
• Perform Antimicrobial effectiveness studies and interpret data.
• Document results as per SOP and GMP standards.

Skills

Microbiology knowledge

Analytical skills

Organizational skills

Communication skills

Problem-solving skills

Education

B.Sc./M.Sc. in Microbiology

Tools

LIMS

TrackWise

Job description

Job Purpose

The main responsibility of this position is to generate accurate results while following GMP requirements. Responsible for microbiological testing in microbiology laboratory, in accordance with established compendial and in-house testing methods, while under minimum supervision.

Duties And Responsibilities

• Microbiological testing as per USP, and for RMs, In-process bulk, F/G and stability samples.
• Microbiological testing of purified water and city water.
• Environmental monitoring including active air, passive air, surfaces, compressed air, and non-viable particulate counts.
• Perform microbial recovery studies for method validation.
• Perform Antimicrobial effectiveness studies and intrinsic antimicrobial testing.
• Antibiotic assays using cylinder plate method and turbidimetric analysis.
• Media preparation, sterilization, and QC testing of culture media for sterility and growth promotion tests.
• Operation and maintenance of microbiology laboratory equipment.
• Document test results as per SOP and GMP.
• Recognize OOS or out-of-trend results and assist in lab investigations under supervisor/manager guidance.
• Interpret data, communicate results, and complete written reports.
• Complete all GMP documentation correctly and in a timely manner.
• Complete all training assignments and maintain personal training records.
• Conduct or lead routine laboratory and Non-Conformance Investigations.
• Initiate and follow through with actions required to close Change Controls.
• Evaluate methods and procedures, suggest improvements as required.
• Interpret data and complete written reports.
• Routine maintenance of microbiology laboratories including cleaning and sanitization.
• Other duties as required.

Additional Responsibility (Customer Facing Roles)

Report any adverse events received from customers for company products to the pharmacovigilance department / Drug Safety within 1 business day.

Qualifications

• B.Sc./M.Sc. in Microbiology.
• Minimum 1-3 years of experience in Pharmaceutical microbiology laboratory environment preferred.
• Strong Microbiology knowledge/experience preferred.
• Ability to apply knowledge of microbiology, math, instrumentation, and statistics.
• Ability to work effectively in a team-based environment.
• Proficiency with applicable software (LIMS, TrackWise).
• Strong organizational, analytical, and multi-tasking skills.
• Ability to troubleshoot and resolve issues.
• Excellent written and verbal communication skills.
• Thorough understanding of GMPs.

Working Conditions

Generally, fairly pleasant surroundings with occasional exposure to higher noise levels, chemicals, and odors. Mixture of standing, walking, and light lifting.

Physical Requirements

Office-based role.

Direct Reports

NA