The basic function of the Microbiology Manager is to conduct quantitative and qualitative analysis of pharmaceutical products according to FDA, cGMP and Boston Analytical, Inc. Standard Operating Procedures. SHIFTS: 1st & 2nd shift available.
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).
- Coordinates work projects to appropriately prioritize laboratory workload to meet client requirements as related to quality, on-time performance and TAT (Turnaround Time).
- Coordinates the scheduling of personnel to maximize productivity.
- Maintains quality performance metrics, conducts routine metrics review and root cause analysis in collaboration with chemists and laboratory management.
- Coordinates and communicates delays and technical issues with management in a timely manner.
- Maintains and performs the peer review process in support of client and laboratory quality objectives.
- Devises and develops processes and methods for the solution of technical problems.
- Performs system maintenance and calibration to ensure equipment is operating within specified requirements.
- Trains, mentors and supervises Microbiologists in their group.
- Reviews lab investigations and deviations with microbiologists in their group. Conducts root cause analysis and implements solutions in collaboration with the chemists.
- Confers with Quality Assurance and Lab Management to design and/or improve standard operating procedures and/or training programs.
- Ensures all work performed is performed in compliance with Standard Operating Procedures, Good Manufacturing Practices, Regulations of the Food and Drug Administration, Company, Client and Pharmacopeial Methodologies.
- Follows all safety rules and regulations.
- Follows all cGMP rules and regulations.
- Documents work in a clear and organized manner.
- Maintain a clean and orderly laboratory environment.
- Proper handling of hazardous waste in compliance with the Company and DES hazardous waste rules.
Qualifications include a Master’s and/or Bachelor’s degree in Microbiology or a related discipline required with 2+ years of experience with Boston Analytical and/or 5+ years of related experience. Knowledge of cGMPs and related compliance regulations and guidances required.
Must have experience with the various products and services the Company offers including stability studies, method development and validation, LIMS, and ELN.
This position requires a self-starting, motivated person who possesses excellent interpersonal skills; who is able to assume a leadership role in the laboratory; and, who is able to effectively interact with all departments within the company and with client personnel.
Minimum Skills Requirements:
- Demonstrated skills in laboratory techniques.
- 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.