Senior Quality Control Microbiologist

Job Title: Senior Quality Control Microbiologist

Location: Portsmouth, NH 03801

Duration: 12 months

Job Type: Temporary Position

Work Type: Onsite

Pay Rate: $25.00 to $30.00/hr.

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 Description:

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

• Bachelor’s 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.