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. Qualifications & Requirements
Education & Experience
- Education: Bachelor’s degree in Microbiology, Biology, Biochemistry, Biotechnology, or a related scientific discipline.
- Experience:
- 1–3 years of hands-on laboratory experience within a cGMP-regulated biotechnology, pharmaceutical, or medical device facility (QC laboratory experience preferred).
- Direct experience performing bioburden, endotoxin testing, environmental monitoring, or utility sampling.
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 education: Bachelors
Responsibilities
Execute routine and time-sensitive quality control microbiology testing and operations within a compliant cGMP laboratory environment.
- 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 (1 year of experience is required)
- Quality Control (1 year of experience is required)
- cGMP (1 year of experience is required)
- GMP (1 year of experience is required)
Qualifications
- Years of experience: 2 years
- Experience level: Experienced
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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. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
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. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
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.