Senior Microbiology Quality Analyst

Portsmouth, OH - USA

Monthly Salary: Not Disclosed

Posted on: 3 hours ago

Vacancies: 1 Vacancy

Job Summary

Overview:

TekWissen group is a workforce management provider throughout the USA and many other countries in the world. Our client is a leading biotechnology company that combines technological expertise with world-class manufacturing and scientific insight to support the delivery of innovative medicines for a wide range of diseases. Specializing in pharmaceutical ingredients bioscience biopharmaceuticals custom manufacturing and cell and gene therapy the company provides comprehensive services across the pharmaceutical biotech and life sciences sectors. It supports every stage of drug development from early research to commercial production and offers solutions in biologics small molecules and specialty ingredients. Committed to quality and innovation the company serves as a critical partner in advancing therapeutic solutions and streamlining complex manufacturing processes with a global presence that ensures access to scalable flexible and compliant technical expertise.

Job Title: Senior Microbiology Quality Analyst

Location: Portsmouth NH 03801

Duration: 12 months

Job Type: Temporary Position

Work Type: Onsite

Summary

The Senior Microbiology Quality Analyst / Quality Microbial Control Analyst V supports the Quality Microbial Control department by ensuring timely high-quality testing for in-process and final drug product lots as well as ongoing stability studies. The role involves working on moderately complex assignments identifying deviations and contributing as a subject matter expert (SME). The analyst may also support team operations special projects and act as a backup to the supervisor when needed.

Responsibilities

Perform testing for In-Process Lot Release and Stability studies
Support Utility and HVAC monitoring and sampling
Review assays and ensure data accuracy
Write and manage Quality Records (Deviations CAPA Change Control)
Develop and update test methods
Participate in projects such as Method transfers New instrument implementation and Method qualifications
Train team members and provide technical guidance
Act as an SME (Subject Matter Expert) within the department
Use laboratory systems and software tools for testing and documentation
Apply Data Integrity principles in compliance with company policies
Identify and report deviations from standard practices
Analyze data and troubleshoot issues of moderate complexity
Serve as backup to the supervisor making independent quality decisions when required
Perform additional duties as assigned

Required Qualifications

Bachelors Degree in Microbiology Biochemistry or related field
5 to 10 years in a relevant role
Strong understanding of GMP environments and Quality Systems (e.g. TrackWise LIMS)
Hands-on experience with microbial testing and lab operations
Proficiency in Microsoft Office Suite (Word Excel PowerPoint)
Experience with laboratory computer systems
Knowledge of Data Integrity (DI) principles
Ability to analyze data and identify deviations
Strong documentation and technical writing skills
Capability to train others and provide technical leadership
Ability to handle moderately complex tasks and projects independently

TekWissen Group is an equal opportunity employer supporting workforce diversity.

Overview: TekWissen group is a workforce management provider throughout the USA and many other countries in the world. Our client is a leading biotechnology company that combines technological expertise with world-class manufacturing and scientific insight to support the delivery of innovativ...