QC Microbiologist II

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Division

Piramal Pharma Solutions

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.

This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.

Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

For more details, please visit : www.piramalpharmasolutions.com

Job Title

Quality Control Analyst II

Job Description

The QC Microbiologist II is responsible for performing a variety of microbiological testing activities to support raw material, in-process, finished product, stability, water, and environmental monitoring programs. Under minimal supervision, this position executes routine and non-routine microbiological testing, supports method development and validation activities, conducts data review and auditing functions, and assists in training laboratory personnel. The role ensures compliance with applicable cGMP, FDA, USP, ICH, and internal quality standards while supporting laboratory efficiency and continuous improvement initiatives.

Key Responsibilities

• Perform routine microbiological testing of raw materials, finished products, stability samples, and other materials as required.
• Conduct water testing, environmental monitoring, media preparation, growth promotion testing, and microbial identification activities.
• Execute microbiological method development, method suitability studies, antimicrobial effectiveness testing (AET), and antibiotic microbial assays.
• Support qualification and validation activities related to microbiological methods and laboratory processes.
• Review and audit microbiological testing data and documentation, including environmental monitoring, water testing, and growth promotion records.
• Prepare, review, and revise standard operating procedures (SOPs), test methods, protocols, and laboratory documentation.
• Train and mentor analysts and technicians on laboratory techniques, procedures, and compliance requirements.
• Support cross-functional laboratory testing needs as required.
• Ensure compliance with cGMP, cGLP, FDA, USP, ICH, and company quality requirements.
• Adhere to Environmental Health & Safety (EHS) policies, procedures, and safe laboratory practices.
• Participate in laboratory investigations, problem-solving activities, and continuous improvement initiatives.
• Perform other duties as assigned to support business needs.
• Work overtime and weekends as needed.

Qualifications & Experience

Required Education

• Bachelor's degree in Microbiology, Biology, or a related Life Sciences discipline.

Required Experience

• Minimum three (3) years of pharmaceutical microbiology laboratory experience with a Bachelor's degree; or
• Advanced degree in a scientific discipline with a minimum of two (2) years of relevant pharmaceutical microbiology experience.

Preferred Experience

• Experience training and mentoring laboratory analysts and technicians.
• Experience supporting microbiological method development, validation, and qualification activities.

Technical Knowledge & Skills

• Strong knowledge of microbiological laboratory techniques and aseptic practices.
• Experience with microbial examination methods, microbial identification, environmental monitoring, and water testing.
• Working knowledge of antibiotic microbial assays and antimicrobial effectiveness testing.
• Familiarity with autoclaves, media preparation, pH meters, balances, plating techniques, and bioassays.
• Thorough understanding of cGMP, cGLP, FDA, USP, and ICH requirements.
• Knowledge of compendial microbiological testing requirements; familiarity with international compendia (e.g., EP) is preferred.
• Proficiency with Microsoft Office applications and Laboratory Information Management Systems (LIMS).
• Strong documentation and data integrity practices.

Core Competencies

• Excellent attention to detail and organizational skills.
• Strong problem-solving and analytical abilities.
• Effective verbal and written communication skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Self-motivated with the ability to work independently.
• Strong collaboration and interpersonal skills.
• Effective time management and project coordination skills.

Physical Requirements

• Ability to lift and move up to 10 pounds regularly and up to 25 pounds occasionally.
• Ability to work in laboratory environments involving hazardous and non-hazardous materials.
• Ability to wear required Personal Protective Equipment (PPE).
• Must not have allergies or sensitivities that would prevent working safely with chemicals or biological materials commonly found in laboratory and manufacturing environments.