Associate Scientist/Microbiology Lab Technician

ZipRecruiter; Birmingham; On-site; GBP 30,000 - 45,000; Full time

Job summary

A leading pharmaceutical company in Birmingham is seeking a skilled microbiologist to perform routine testing and support manufacturing activities. Candidates must have a Bachelor's degree and at least one year of professional laboratory experience. Responsibilities include conducting microbiological assays, documenting results in compliance with GMP, and developing standard operating procedures. A focus on safety and adherence to health policies is essential for this role.

Qualifications

• Minimum one year of professional experience in microbiology.
• Experience with laboratory testing and pharmaceutical processes is required.
• Ability to troubleshoot instrumentation in laboratory settings.

Responsibilities

• Perform routine microbiological testing and assays.
• Document results according to GMP standards.
• Develop and execute standard operating procedures.

Skills

Microbiological Assays and Testing

Validation Support

GMP Documentation

Technical Writing

Safety and Compliance

Education

Bachelor's degree in related field

Tools

Laboratory Information Management System

Microbiology Information Management Systems

Job description

Job Description

Overview

Monday to Friday 8am to 5pm. USP 61 & 85 Testing not required but. Will need to have one-year professional experience (not including college labs). Lab testing exp. Pharmaceutical experience. Bachelor's degree Required in related field.

Responsibilities

• Has a sound understanding of the skills required to perform routine testing activities in microbiology, including:
• Microbiological Assays and Testing – a) Turbidimetric/Chromogenic/Gel Clot method for the detection of bacterial endotoxins; b) Microbial Limits Test/Bioburden determination, manipulation, and maintenance of ATCC microorganisms and microbial isolates; c) Sterility Test, Growth Promotion and Particulate Matter determination using instrumentation and/or microscopy; d) Identification of bacteria and fungi using microscopy and phenotypic/genotypic methods; e) perform sample shipments to contract testing laboratories.
• Validation Support – Ability to perform bioburden swab testing by current detection methods; ability to perform biological indicator testing by current methods; ability to perform endotoxin challenge vial testing.
• GMP Documentation – Document test results and conclusions in a GMP manner; ensure test forms are complete before submission for approval. Data entry for finished products and raw material in Laboratory Information Management System. Performs responsibilities in compliance with quality systems and regulatory requirements. Adheres to all company safety, health and environmental policies, procedures, and directives. Conducts all laboratory activities in a safe manner by use of SDS and Safety Notifications to establish chemical hazards, observes appropriate laboratory procedures and reports incidents that could threaten safety. Ensures all equipment is in a GMP/validated/calibrated state before use.
• Technical Writing – Develop and execute protocols and Standard Operating Procedures for the implementation of microbiology equipment, assays and test methods. Reviews data generated by laboratory personnel. Provides guidance and training to other laboratory personnel on operation of instruments and performing test methods. Ability to troubleshoot instruments in the event of problems. Utilizes classical microbiological methods for the identification of microorganisms per Bergey's Manual of Systematic Bacteriology. Support of Environmental Monitoring Program: Utilities – Testing of clean steam, USP water, and Water for Injection for bioburden, total organic carbon (TOC), and presence of endotoxins; and nitrogen and process air for total microbial count and total particulates. Environmental Monitoring of facilities for non-viable particulates, viable air and surface by use of calibrated and validated monitoring equipment and procedures.
• Other Responsibilities – Performs responsibilities in compliance with quality systems. Adheres to all company safety, health and environmental policies, procedures and directives. Conducts all laboratory activities in a safe manner by use of SDS to establish chemical hazards, observes appropriate laboratory procedures and reports incidents that could threaten safety of laboratory personnel. Data analysis and entry into software systems such as Microbiology Information Management Systems (MIMS).

Strategic Focus

(MIMS) STRATEGIC FOCUS: The focus desired and expected on the position over the next 1-3 years. Perform responsibilities in compliance with quality systems and provide support to all manufacturing activities. Adhere to all company environmental, health and safety policies and procedures. Conduct all laboratory and cleanroom activities in a safe manner and according to appropriate written procedures. Perform microbiological assays according to US, EU, ISO regulations and procedures and test methods. Maintain the laboratory metrics program. Complete the qualification of sanitizers used in the manufacturing facilities.