Quality Control, Analyst II

Job Title: Qc Analyst Ii (Environmental Monitoring)

Position Summary:

Forge Biologics is seeking a Quality Control Analyst II (Environmental Monitoring) to join our growing team. This role is a key contributor to the Environmental Monitoring (EM) program, supporting the aseptic manufacturing environment and ensuring compliance with GMP standards. The QC Analyst II will lead EM initiatives, mentor junior analysts, and drive continuous improvement in EM practices and systems. This position requires a strong technical background, leadership capabilities, and a proactive approach to problem-solving in a fast-paced GMP environment.

Key Responsibilities:

• Lead and coordinate EM sampling activities, ensuring adherence to GMP principles and regulatory requirements.
• Perform advanced environmental monitoring including viable and non-viable air, surface, and personnel monitoring in classified cleanroom areas.
• Analyze and trend EM data using statistical software (e.g., JMP, LIMS) and generate reports for internal and regulatory use.
• Lead and support complex investigations, including root cause analysis for OOS and deviations, and implement CAPAs.
• Mentor and train junior QC Analysts in EM techniques, aseptic behavior, and GMP documentation practices.
• Support and lead EM-related activities during Media Fills/Process Simulations and EMPQ.
• Collaborate with cross-functional teams including Manufacturing, QA, and Facilities to ensure environmental control and compliance.
• Author and review SOPs, protocols, and technical reports related to EM.
• Participate in audits and inspections, providing subject matter expertise on EM practices and data.
• Drive continuous improvement initiatives within the EM program, including implementation of new technologies and process optimizations.

Qualifications:

• Bachelor’s degree in Microbiology, Biology, or a related scientific field required.
• 2+ of experience in a GMP-regulated QC or EM environment.
• Demonstrated expertise in aseptic technique and cleanroom behavior.
• Strong understanding of FDA, EMA, and ICH regulations related to environmental monitoring and GMP compliance.
• Proficiency in data analysis tools (e.g., JMP, LIMS) and Microsoft Office Suite.
• Excellent communication, organizational, and leadership skills.
• Ability to work independently and manage multiple priorities in a dynamic environment.
• Willingness to work flexible hours to support production schedules and EM requirements.
• Ability to work in cleanroom environments with appropriate PPE and gowning.

Preferred Skills:

• Experience leading EM programs or projects.
• Prior involvement in regulatory inspections or audits.
• Familiarity with risk assessment tools and quality systems.