QC Analyst

Title: QC Analyst

Location: Portsmouth, NH

Duration: 6+ months with extension

Job Description: 

We are seeking an QC Analyst to support routine testing and environmental monitoring activities within a regulated laboratory and cleanroom environment. The ideal candidate will have 1–4 years of relevant experience and an educational or professional background in Biology, Microbiology, Chemistry, or a related scientific discipline.

The consultant will receive assigned sample lists and be responsible for executing testing, environmental monitoring, documentation, and data entry activities in accordance with established procedures and GMP requirements.

Key Responsibilities

·         Perform routine environmental monitoring (EM) activities within laboratory and cleanroom environments.

·         Receive and execute testing based on assigned sample lists and testing schedules.

·         Perform sample collection, handling, testing, and documentation in accordance with SOPs.

·         Conduct environmental monitoring activities, which may include:

·         Viable and non-viable air monitoring

·         Surface sampling/contact plates

·         Personnel monitoring

·         Cleanroom monitoring

·         Microbiological sampling and testing

·         Follow proper gowning procedures for entry into controlled laboratory and cleanroom environments.

·         Accurately document testing activities, sample information, and results.

·         Enter and maintain testing/sample data within LIMS and MODA systems.

·         Follow applicable GMP, GDP, SOP, and laboratory procedures.

·         Identify and escalate abnormal results, discrepancies, or deviations as appropriate.

·         Collaborate with QC, Microbiology, Manufacturing, and other cross-functional teams as needed.

Qualifications

·         1–4 years of experience within Quality Control, Environmental Monitoring, Microbiology, or a related laboratory function.

·         Biology, Microbiology, Chemistry, or a related scientific field preferred.

·         Hands-on experience with environmental monitoring and/or sample testing in a regulated environment.

·         Experience working in cleanrooms and following gowning procedures.

·         Familiarity with LIMS required or strongly preferred.

·         Experience with MODA is highly preferred.

·         Previous experience within a GMP pharmaceutical, biotechnology, or similar regulated environment preferred.

·         Strong attention to detail and ability to accurately follow established sample lists, testing schedules, and SOPs.