Impactful QC Environmental Monitoring Analyst II

PCI Pharma Services; Bedford (NH); On-site; USD 65,000 - 90,000; Full time

Job summary

PCI Pharma Services in Bedford, NH is seeking a QC Environmental Monitoring Analyst II to join the Quality Control team. This role focuses on routine environmental monitoring of classified clean rooms, sampling water systems, and ensuring compliance with cGMP standards.

The 12-hour rotating shift and AM hours support continuous manufacturing operations. Ideal candidates hold a high school diploma or degree in microbiology or related field, with 5–7 years in a cGMP environment and strong

Qualifications

• High school Diploma, GED, or equivalent; AS/BS in Microbiology preferred.
• 5-7 years in a cGMP environment; combination of education and experience considered.
• Detail-oriented with strong organizational skills and accuracy.
• Adaptable to changing priorities and deadlines; professional verbal communication.
• Excellent computer skills; ability to learn new software quickly.
• Ability to work varied hours as production requires and gown to ISO standards.
• Experience with lab equipment and analytical methods may be required.
• Ability to identify and implement process improvements.
• Knowledge of ISO-8 to ISO-5 gowning for controlled environments.
• Strong documentation and SOP adherence.
• Comfort with hazardous materials and safety procedures.
• Ability to collaborate across teams and train staff.

Responsibilities

• Performs routine Environmental Monitoring of the classified clean rooms.
• Performs routine utility sampling and analysis of Water for Injection Systems, RO/DI, USP Purified water systems, and Clean Steam systems.
• Monitors classified clean rooms during manufacturing operations; must be gown qualified.
• Performs routine monitoring and analysis of the Clean Compressed Air System.
• Executes protocols/experiments/SOPs under minimal supervision.
• Reviews work of peers and SOP document changes under minimal supervision.
• Assists senior staff in preparation of investigations, reports and execution of complex protocols.
• Assists in authoring and collaborating on SOP creation and updates.
• Conducts visual inspection of media fill vials and plates.
• Trains staff in routine processes.
• Performs general lab maintenance/housekeeping.
• All other duties as assigned.

Skills

Detail-oriented

Verbal communication

Computer skills

Lab instrumentation knowledge

Troubleshooting

Process improvements

Adaptability

Time management

Education

BS degree in Microbiology or related field

High school Diploma, GED, or equivalent

Tools

Laboratory instrumentation

Job description

PCI Pharma Services in Bedford, NH is seeking a QC Environmental Monitoring Analyst II to join the Quality Control team. This role focuses on routine environmental monitoring of classified clean rooms, sampling water systems, and ensuring compliance with cGMP standards.

The 12-hour rotating shift and AM hours support continuous manufacturing operations. Ideal candidates hold a high school diploma or degree in microbiology or related field, with 5–7 years in a cGMP environment and strong