The QC Microbiologist II conducts quantitative and qualitative analysis of pharmaceutical products according to FDA, cGMP and Boston Analytical, Inc. Standard Operating Procedures. Duties will include analysis of pharmaceutical products through compendial methods and client specific test protocols.
Primary Duties and Responsibilities
- Prepares and analyzes samples to determine microbiological quality through the following analyses: Microbial enumeration methods, absence of specified microorganisms, endotoxin, and water quality analysis (bioburden, TOC, Conductivity).
- Performs genetic analysis of microbial growth to determine Genus/Species of unknown isolates.
- Collects Environmental Monitoring Samples onsite and offsite at client manufacturing sites.
- Documents work in a clear and organized manner.
- Authors and revises procedures and ELNs under minimal supervision. Takes the lead on document stream-lining.
- Follows all safety rules and regulations and conducts periodic safety audits.
- Follows all cGMP rules and regulations.
- Will perform work under partial supervision and will provide oversite to projects and assist other Microbiologists as needed.
- Under partial supervision, confers with Microbiologists and other client personnel regarding research, procedures performed, related results and prepares reports.
- Is a subject matter expert in some techniques and will mentor others. Works to learn and improve on others techniques and tasks.
- Performs data generation, analysis and more complicated problem solving with minimal rework.
- Reviews and assesses deviations; includes performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting.
- Works under partial supervision to ensure all work performed is executed in compliance with standard operating procedures, good manufacturing practices, and the regulations of the Food and Drug Administration.
- Ensures all work performed strictly adheres to Company, client and Pharmacopeial methodologies.
- Performs system maintenance and calibrations to ensure equipment is operating with specified requirements.
Proper handling of hazardous waste in compliance with the Company and DES hazardous waste rules.
Qualifications include a BA or BS degree in Microbiology or related science discipline with 1-5 years of related experience is required. Knowledge of cGMPs and related compliance regulations and guidances is required.
Minimum Skills Requirements:
- Must have the ability and skill to perform the detailed job requirements noted above competently, safely and proficiently.
- A self-starter, motivated person who possesses good interpersonal skills capable of effectively interacting with all departments and client personnel.
- Must have excellent organizational, verbal communication and technical documentation skills.
- Solid computer skills.
- Knowledge of safe laboratory practices, including the proper procedures in handling chemicals and samples.
- Must be a team player with integrity and concern for the quality of Company products, services and staff members.