What are the responsibilities and job description for the Microbiologist II position at Piramal Pharma Solutions?
Business: Pharma Solutions
Department: Microbiology (MQC)
Location: Lexington, KY
Job Overview
The primary purpose of the role is to perform microbiological testing of raw materials, work-in-process, and finished products, while maintaining compliance of laboratory standard operating procedures.
Reporting Structure
Directly reports to Supervisor Microbiology
Key Responsibilities
- Develop microbiological test methods and method validations.
- Perform microbiological testing of raw materials, work-in-process, and finished product for product approval and release.
- Prepare protocols, final reports, and test methods related to the development and validation of microbiological methods.
- Perform growth promotion of media and maintenance of bacterial cultures.
- Provide support to facility to resolve nonconformance issues and identify corrective and preventative actions as related to environmental monitoring excursions
- Complete environmental monitoring and laboratory related investigations and properly document results.
- Maintain GMP/GLP documentation relevant to the duties and responsibilities assigned.
- Maintain laboratory instrumentation required for testing and cleanliness of the laboratory per SOP guidelines.
- Assist in the review of test data and report any deviations to supervisor.
- Interact and coordinate activities with other departments and external vendors to support and meet the facility goals and objectives
- Assist management in writing/updating Standard Operating Procedures (SOPs)
- Participate in projects involving the Quality Control and/or Microbiology departments
- Train team members in microbiology and chemistry laboratories as required
- Ensure proper handling and disposal of biohazard material in compliance with OSHA and Standard Operating Procedures
- Compose and assist with quality systems documentation such as failure investigations, CAPA, calibration, changes control, etc.
- Compose microbiological trending reports and protocols
- Perform other related duties as required
Education Requirements
- B.S. in Microbiology, Biology, Life Sciences, or related field
Work Experience
- 2 years of practical laboratory experience in a manufacturing environment
- Experience with general documentation practices and GMP compliance with data entry forms with specific attention to details
- Working knowledge and practical experience with good laboratory practices in a microbiology lab environment and competency with microbiology techniques such as Gram staining, isolation plating, media preparation and microorganism identification methods
- Experience with common microbiology lab instrumentation is a requirement, especially with autoclaves, air samplers, light microscope, biohazard cabinets and water purification system.
- Practical hands on experience with basic lab equipment such as pH, balances, water baths and other equipment common to microbiology methods.
Functional or Technical Skills
- Must understand basic lab safety, bio-hazard and chemical waste disposal practices
- Experience with general documentation practices and GMP compliance with data entry forms with specific attention to details.
- Knowledge of cGMP’s and understand the pharmaceutical industry expectations
- Intermediate proficiency in MS Office (i.e. MS Word, MS Excel, Access, Outlook)