QC Microbiology Analyst

Randstad USA; Marlborough (MA); On-site; USD 63,000 - 64,000; Full time

Benefits offered by this job

Medical

Prescription

Dental

Vision

AD&D

Life Insurance

Short-term Disability

401K Plan

Job summary

Randstad USA seeks a detail-oriented QC Microbiology Analyst to join our Quality team in Marlborough, MA. You will perform microbiological testing, environmental monitoring, and data integrity tasks in a cGMP setting. The ideal candidate has a Bachelor’s degree and 5+ years in QC Microbiology, with experience in LIMS/ELN/QMS and compliant documentation.

Shift includes first shift with potential overtime. This role emphasizes GDP, data integrity, and collaboration with Manufacturing Operations on

Qualifications

• Bachelor's degree in a scientific discipline.
• 5+ years in a lab with focus in QC Microbiology.
• Ability to learn and apply GxP regulations (GMP/GLP/GDP).

Responsibilities

• Perform microbiological and critical utility testing.
• Operate and maintain cGMP lab operations and documentation.
• Support method qualification and method transfer activities.
• Enter data into LIMS and ensure data integrity.
• Prepare deviations, CAPAs, and quality records.

Skills

Microbiology

Quality Control

cGMP

GMP

Education

Bachelor's degree

Tools

LIMS

ELN

QMS (Veeva)

QMS (TrackWise)

Job description

Job Title

Quality Control (QC) Microbiology Analyst

Department

Quality Control / Manufacturing Operations Pharmaceuticals

Position Type

Full-Time Hours/Contractor (6 months initial assignment)

Position Overview

We are seeking a detail-oriented QC Microbiology Analyst to join our Quality team. In this role, you will perform microbiological and critical utility testing, environmental monitoring, and laboratory operations in a regulated cGMP manufacturing environment. You will be responsible for ensuring that all analytical data adheres to rigorous Data Integrity and Good Documentation Practices (GDP) while supporting both routine testing and time-sensitive STAT manufacturing support. Your work will span routine microbiological testing, method qualification support, laboratory readiness, and compliant documentation, with opportunities to support special projects as needed.

Qualifications & Requirements

Here’s What You’ll Need (Basic Qualifications)

Minimum education required: Bachelor’s degree in a relevant scientific discipline

Minimum experience required: 5 years in a laboratory setting with focus in QC Microbiology

Demonstrated aptitude or ability to learn to gain anunderstanding of GxP regulations (specify GMP.GLP, GCP, GDP or other applicable standards)

Technical Competencies

• practical understanding of cGMP regulations (21 CFR Part 210/211), USP/EP compendial microbiological methods, and Data Integrity standards (ALCOA+).
• Familiarity with electronic laboratory systems, including LIMS, electronic lab notebooks (ELN), and QMS platforms (e.g., Veeva, TrackWise).
• Proven competence in aseptic technique and working within classified cleanrooms

Key Skills & Attributes

• technical writing skills with experience drafting SOPs or deviation reports.
• Excellent organizational skills with the ability to manage competing priorities in a fast-paced environment.
• High attention to detail, accuracy in data recording, and integrity in escalation processes.
• Willingness to work flexible hours, including occasional evenings or weekends, to support production runs.

Salary

$46 - $46.5 per hour

Shift

First

Work Hours

8 AM - 6 PM

Responsibilities

• Testing & Sampling: Perform bioburden, endotoxin, TOC, conductivity, sterility, growth promotion, critical utility sampling, and environmental monitoring (EM). Review associated analytical test data. Support STAT process testing for manufacturing, maintaining shift flexibility as needed.
• Method & Equipment Support: Support method acquisition, qualification, and re-qualification protocols. Troubleshoot assays and instrumentation. Author and revise equipment procedures, test methods, laboratory SOPs, and reports.
• Lab Operations & Maintenance: Handle reagent preparation, sample lifecycle management, instrument maintenance, and housekeeping to sustain audit-ready facilities. Support special projects and approved pilot programs (such as evaluating generative AI for lab-support tasks).
• Data Integrity & LIMS: Enter sample results into LIMS, execute electronic assay forms, and assist with data trending and performance analysis.
• Quality & Compliance: Strictly enforce cGMP, GxP, Good Documentation Practices (GDP), and data integrity standards. Author quality records including deviations, CAPAs, and change controls. Complete assigned learning curricula and requalification cadences on schedule.

Skills

• Microbiology (5 years of experience is required)
• Quality Control (5 years of experience is required)
• cGMP (5 years of experience is required)
• GMP (5 years of experience is required)

Qualifications

• Years of experience: 2 years
• Experience level: Experienced

Equal Opportunity Statement

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants.

Benefits

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc.

• medical
• prescription
• dental
• vision
• AD&D
• life insurance offerings
• short-term disability
• 401K plan (all benefits are based on eligibility)

Posting Duration

This posting is open for thirty (30) days.

Legal Disclaimer

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Experience

• Experienced
• 2 years

Education

• Bachelors