QC Microbiologist I

Profile

Summary:

The Quality Control Microbiologist I perform quality activities in support of product production and releases. The QC Microbiologist I performs a wide variety of activities to ensure compliance with applicable regulatory requirements by conducting testing, trending, and reporting results.

Essential Duties and Responsibilities:


Perform microbiological testing (endotoxin, bioburden) for water. Perform microbiological testing (endotoxin, sterility, and bioburden) for raw materials, in-process materials, intermediates, and final products. Perform environmental monitoring of the clean rooms (under USP and EU specifications).

Read, trend, and report environmental, personnel, in-process, raw material, finished product, and water testing results. Perform microbial characterization (gram stain, catalase, oxidase, and coagulase tests). Prepare and send out samples for microbiological identification.

Maintain historical files on organisms found in classified areas; microbial identification and trending. Perform line clear and line start verifications. Inspection of media fills. Perform other microbiological assays: Sterility (including Biological Indicator testing) and growth promotion testing of all incoming media used in the microbiology laboratory.

Microbial Limits/Enumeration testing. QC microbiological sample receipt for internal testing, login, processing, tracking, distribution of test results, and closure. Initiate OOS or Environmental Monitoring Excursion Investigations.

Provide Support of general QC Microbiology Laboratory activities. Chart reading and changing. Equipment cleaning and maintenance. Maintaining supplies and inventory. General laboratory housekeeping

Education and/or Experience:



Bachelor’s degree in a scientific discipline, preferably microbiology with less than three (3) years of previous professional experience.

Strong organizational skills and ability to prioritize and multi-task in a fast-paced environment. Minimum of 1-3 years of industry experience in a GMP or GLP environment preferred. Proficient in the validation/qualification of lab microbiological techniques preferred. Must be skilled in the use of computers and proficient in the use of spreadsheets. Previous experience with pharmaceutical cleanroom environments. Knowledgeable in FDA cGMPs (21 CFR 211); ISO 9001, 13485, and 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.

Mathematical Skills:

Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.

Reasoning Ability:

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Computer Skills:

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

Other Skills and Abilities:



Facilitate the revision and release of all controlled documents. Facilitate mandatory reviews of SOPs and month-end reports.

Provide oversight for projects to update/maintain official document templates. Direct and manage the Change Control System

Other Qualifications:

Must pass a background check

Must pass a drug screen

Physical Demands:

While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit and use hands to finger, handle, or feel. The employee is occasionally required to stand; walk; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, and depth perception.

Work Environment:

While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts; high, precarious places; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock; explosives; risk of radiation, and vibration. The noise level in the work environment is usually moderate.

All interested applicants must apply online. **MEMBERS ONLY**SIGN UP NOW***. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability.

Note:

This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an “at-will” relationship.

Company info

Sign Up Now - ScientistCrossing.com