QC Scientist I

Job Description

Job Summary:

• Perform Environmental Monitoring activities within classified cleanrooms supporting sterile manufacturing operations.
• Execute routine and non-routine environmental sampling, process and review generated data, and support the assessment of cleanroom environmental conditions in accordance with approved procedures, Good
• Manufacturing Practices (GMPs), and site quality standards.

Duties and Responsibilities:

• Perform routine Environmental Monitoring sampling within classified areas, including viable and non-viable monitoring activities, in accordance with approved procedures and established sampling plans.
• Collect, document, and process Environmental Monitoring samples and associated data accurately and in a timely manner.
• Review Environmental Monitoring results a Products established specifications, alert/action levels, and acceptance criteria; identify and escalate excursions, atypical results, or other concerns in accordance with applicable procedures.
• Perform data entry, calculations, data processing, and documentation within applicable laboratory and Environmental Monitoring databases and systems.
• Support the review and evaluation of Environmental Monitoring data to assess the ongoing state of control of classified cleanrooms.
• Provide Environmental Monitoring oversight of assigned classified areas by observing environmental conditions, identifying potential issues, and communicating observations or concerns to appropriate personnel.
• Support investigations associated with Environmental Monitoring excursions, deviations, and other events by providing accurate data, documentation, and technical input as appropriate.
• Maintain an understanding of applicable SOPs, sampling procedures, GMP requirements, and Environmental Monitoring program expectations.
• Ensure Environmental Monitoring activities and associated documentation are performed in accordance with GMP requirements, data integrity principles, and site procedures.
• Operate and maintain Environmental Monitoring equipment and supplies in accordance with applicable procedures; identify equipment or procedural issues and escalate as appropriate.
• Collaborate effectively with Manufacturing, Quality Assurance, Microbiology, and other cross-functional groups to support manufacturing operations and maintain compliant cleanroom conditions.
• Complete required documentation and records accurately, contemporaneously, and in accordance with applicable procedures.
• Organize and manage assigned activities to meet established timelines and operational requirements.
• Complete all required safety, quality, GMP, and job-specific training.
• Follow applicable safety requirements and established cleanroom gowning and aseptic practices while performing assigned activities.
• Perform additional duties and responsibilities as assigned by area supervision or designee.

Education and Experience:

• Bachelor’s degree in Biology, Microbiology, Biochemistry, or a related scientific discipline is preferred; however, an equivalent combination of education, training, and relevant experience will be considered.
• Previous experience in Environmental Monitoring, cleanroom operations, aseptic manufacturing, pharmaceutical manufacturing, or another regulated environment is preferred but not required.

Knowledge, Skills, and Abilities:

• Basic understanding of scientific principles and the ability to learn Environmental Monitoring techniques, cleanroom practices, and applicable GMP requirements.
• Ability to accurately follow detailed procedures, sampling instructions, and established practices in a regulated environment.
• Strong attention to detail with a commitment to accurate, complete, and timely documentation.
• Strong organizational, problem-solving, and critical-thinking skills.
• Ability to review data, recognize atypical results or conditions, and appropriately communicate and escalate potential issues.
• Proficiency with Microsoft Office applications, including Excel and Word; experience with laboratory information management systems (LIMS), Environmental Monitoring systems, or similar databases is a plus.
• Effective written and verbal communication skills and the ability to work collaboratively with cross-functional teams.
• Ability to work effectively in a fast-paced manufacturing environment, manage assigned responsibilities, and adapt to changing priorities.
• Ability to perform basic mathematical calculations and data analysis.
• Ability to work independently within established procedures while recognizing when additional guidance or escalation is appropriate.

Physical Requirements:

• Position requires ordinary ambulatory skills and physical coordination sufficient to move throughout laboratory, manufacturing, and classified cleanroom areas.
• Ability to stand and walk for prolonged periods and to periodically stoop, kneel, squat, crouch, bend, and reach while performing Environmental Monitoring and other job-related activities.
• Ability to lift, carry, and/or move light to medium weights of approximately 25–50 pounds, with occasional pushing or pulling of 50–100+ pounds, as required.
• Requires sufficient arm, hand, and finger dexterity to perform sampling activities, handle equipment and materials, and operate computers and instrumentation for prolonged periods.
• Visual acuity sufficient to read procedures, labels, documentation, computer monitors, and instrumentation displays.
• Ability to sit, reach with hands and arms, communicate, and hear for prolonged periods as required.
• The position requires the ability to work in classified cleanroom environments while wearing required personal protective equipment (PPE) and cleanroom garments for extended periods.