Microbiology Lead Analyst

at  Compounders International Analytical Laboratories CIAL

SUMMARY:

The Microbiology Lab Lead Analyst performs a wide variety of activities to ensure compliance with applicable regulatory requirements by conducting testing, trending and reporting results. The lead is primarily responsible for managing their team to produce quality testing while maintaining a good attitude. Our ideal candidate is hard-working, trustworthy and able to work with the team to solve problems. The lead is expected to perform testing as needed.

EDUCATION AND/OR EXPERIENCE:

• Bachelor’s degree in a scientific discipline, preferably microbiology.
• Strong organizational skills and ability to prioritize and multi-task in a fast-paced environment.
• Proficient in the validation/qualification of lab microbiological techniques.
• Industry experience in a regulated environment.
• Previous management or leadership experience.
• Must be skilled in the use of computers and proficient is the use of spreadsheets.
• Previous experience with pharmaceutical cleanroom environments.
• Knowledgeable in USP, FDA cGMPs (21 CFR 211) and ISO 17025 a plus.

LANGUAGE SKILLS:

Ability to write reports and correspondence. Ability to speak effectively before groups of customers or employees. Proficient and comfortable in business meetings and work related social and business development situations. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals and communicate this information to others.

COMPUTER SKILLS:

To perform this job successfully, an individual should have knowledge of LIMS software; Spreadsheet software, MAC OS, and Word Processing software.

OTHER SKILLS AND ABILITIES:

• Facilitate the revision and release of all controlled documents
• Facilitate mandatory reviews of SOPs and reports
• Provide oversight for projects
• Direct and manage direct reports
• Willingness to work until the tasks for the day are complete to meet customer needs

OTHER QUALIFICATIONS:

Must pass background check
Must pass drug screen

• Perform microbiological testing (endotoxin, sterility, sterility method suitability and antimicrobial effectiveness) for raw materials, in-process materials, intermediates and final product.
• Directs microbiology investigations as the lead investigator, proposes appropriate changes and assures that changes are completed properly and on-time
• Perform environmental monitoring of the clean rooms (under USP specifications).
• Accurately prepares formal laboratory documentation including, microbiology test methods, SOPs, procedural guidelines, and microbiology related sections of regulatory submissions, and annual reports.
• Prepare and send out samples for microbiological identification.
• Growth promotion testing of incoming media used in the microbiology laboratory.
• Microbial Limits/Enumeration testing
• Initiate OOS or Environmental Monitoring Excursion Investigations
• Provide contributions to the management team
• Equipment cleaning and maintenance
• Maintaining supplies and inventory
• Manages department resources
• Develop and implement new procedures
• Develop methods in accordance with USP and FDA requirements when necessary