Quality Control Scientist II

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

Responsibilities

• 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.

Qualifications

• 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 cleanrooms and aseptic manufacturing operations.
• Demonstrated history of mentoring laboratory personnel and delivering technical GMP training.
• Strong knowledge of cGMP regulations and technical writing skills.

Skills

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

Pay

$45 - 55 per hour

Schedule

9 to 5, day-shift

Benefits

• Medical, prescription, dental, and vision insurance offerings
• AD&D and life insurance
• Short-term disability
• 401K plan

Location: Westborough, Massachusetts
Job type: Contract
Education: Bachelor's degree