Quality Control Scientist II

Job summary

Advance your career as a Scientist II QC Microbiology with a top-tier global pharma leader operating in a dynamic GMP facility. In this high-impact, day-shift role, you will serve as a senior technical subject matter expert, driving robust microbiological testing programs, mentoring laboratory staff, and ensuring strict contamination control compliance.

Westborough, Massachusetts

Contract

$45 - 55 per hour

9 to 5

Bachelors

• Serve as the senior SME for environmental monitoring, sterility, endotoxin, mycoplasma, bioburden, and microbial identification testing programs.
• Develop and execute aseptic technique and contamination control training programs for manufacturing and QC personnel.
• Author, review, and approve SOPs, validation protocols, investigation reports, and technical documentation under cGMP guidelines.
• Lead environmental monitoring data trending and interpretation to evaluate risk and strengthen overall contamination control strategies.
• Manage quality system deliverables, including deviations, CAPAs, Change Control, and root-cause laboratory investigations.
• Deliver technical representation and documentation support during regulatory inspections and quality audits.

• BS in Biology/Microbiology with 10+ years OR MS with 6+ years of relevant cGMP QC microbiology experience.
• Advanced expertise in environmental monitoring, bioburden, endotoxin, sterility, mycoplasma, and microbial identification.
• Proven experience supporting clean rooms and aseptic manufacturing operations.
• Demonstrated history of mentoring laboratory personnel and delivering technical GMP training.
• Strong knowledge of cGMP regulations and technical writing skills.

#LI-AM1

Environmental Monitoring, Microbiology, Aseptic Technique, SOP Development, Good Manufacturing Practices (GMP), Corrective and Preventive Actions (CAPA), Deviation Investigation, Change Control Management, Quality Control (QC)

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

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.

• BS in Biology/Microbiology with 10+ years OR MS with 6+ years of relevant cGMP QC microbiology experience.
• Advanced expertise in environmental monitoring, bioburden, endotoxin, sterility, mycoplasma, and microbial identification.
• Proven experience supporting clean rooms and aseptic manufacturing operations.
• Demonstrated history of mentoring laboratory personnel and delivering technical GMP training.
• Strong knowledge of cGMP regulations and technical writing skills.

#LI-AM1