QC Scientist I

About the Role

As a QC Scientist I – Environmental Monitoring, you will perform Environmental Monitoring activities in support of sterile pharmaceutical filling operations. This is a hands-on role that works directly within classified manufacturing environments and is not a traditional bench laboratory position. You will collect environmental samples within filling suites, monitor controlled environments, follow aseptic practices and good documentation requirements, and accurately record and communicate results. You will work closely with Operations, Quality, and other team members to help maintain the environmental controls necessary to manufacture sterile pharmaceutical products safely and compliantly. This is an excellent opportunity to begin or grow a career within the pharmaceutical industry while gaining experience in aseptic processing, Environmental Monitoring, Good Manufacturing Practices (GMP), and sterile manufacturing operations.

Key Responsibilities

• Perform routine Environmental Monitoring activities within classified cleanrooms and aseptic processing areas in support of sterile filling operations.
• Collect environmental samples within manufacturing and filling suites in accordance with approved procedures.
• Perform monitoring activities associated with aseptic core areas, isolator lines, and other controlled manufacturing environments.
• Follow established procedures for environmental and personnel monitoring while maintaining appropriate aseptic technique.
• Accurately document activities and results in accordance with Good Documentation Practices, ALCOA principles, GMP requirements, and site procedures.
• Generate and record accurate, complete, legible, and contemporaneous documentation.
• Review Environmental Monitoring information and communicate observations, issues, or unexpected results to the appropriate team members.
• Communicate effectively with assigned manufacturing lines, supervisors, and incoming shifts to ensure appropriate handoffs and continuity of work.
• Complete routine Environmental Monitoring activities performed on weekly, biweekly, monthly, and production-driven schedules.
• Maintain assigned equipment and verify equipment is ready and appropriate for use.
• Follow Standard Operating Procedures (SOPs), safety requirements, and established Quality procedures.
• Maintain required training and qualification status for work within classified and aseptic areas.
• Work both independently and collaboratively after completing the appropriate training and qualification process.
• Maintain an organized work area and appropriately handle Environmental Monitoring equipment and materials.
• Escalate roadblocks, incomplete activities, environmental concerns, or documentation issues to supervision as appropriate.
• Perform other duties as assigned.

Requirements & Tech Stack

• 12 hr shift/nights work schedule.
• 2-2-3 rotating schedule with 15% shift differential.
• Laboratory Setting, Office, Cleanroom.
• Personal Protective Equipment (PPE) required, including safety glasses, gowning, gloves, lab coat, ear plugs.
• Ability to lift 40 lbs. without assistance.
• Adherence to all Good Manufacturing Practices (GMP) Safety Standards.
• Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc. allowed.
• Loud Noises (Equipment/Machinery).
• Environmental Conditions.

Qualifications

• Education
• Associate degree in a science-related field is required.
• Bachelor’s degree in Biology, Microbiology, or another related science field is preferred.
• Equivalent combinations of education, training, and relevant work experience may be considered.
• Experience
• Previous experience in Environmental Monitoring, microbiology, pharmaceutical manufacturing, aseptic processing, cleanroom operations, or another regulated environment is preferred but not required.
• Candidates with an associate degree and relevant pharmaceutical or Environmental Monitoring experience may also be considered.
• Previous experience with microbiological testing or Environmental Monitoring is particularly valuable.
• Knowledge, Skills, and Abilities
• Strong attention to detail and commitment to accurate documentation.
• Ability to learn and consistently follow GMP, Good Documentation Practices, ALCOA principles, SOPs, and other regulatory requirements.
• Interest in or understanding of Environmental Monitoring within a pharmaceutical manufacturing environment.
• Ability to learn and apply aseptic techniques and gowning requirements.
• Strong written and verbal communication skills.
• Ability to communicate effectively during shift handoffs and with manufacturing, Quality, supervisors, and other colleagues.
• Ability to work effectively both independently and as part of a collaborative team.
• Proactive approach to completing assigned work and communicating roadblocks or concerns.
• Ability to organize work and manage assigned activities in a fast-paced manufacturing environment.
• Working knowledge of Microsoft Office applications and ability to accurately enter and transcribe data.
• Ability to follow detailed procedures and maintain accurate, legible, and contemporaneous records.
• Willingness and ability to work a 12-hour rotating night-shift schedule.
• Physical Requirements / Work Environment
• Requires work within classified cleanroom and aseptic manufacturing environments and the ability to successfully complete applicable gowning and aseptic qualifications.
• Requires extended periods of standing and walking.
• Ability to bend, reach, stoop, kneel, squat, and crouch periodically.
• Ability to lift, carry, and move equipment and materials, typically weighing approximately 10–40 pounds.
• Sufficient hand and finger dexterity to operate equipment and computer systems.
• Visual acuity necessary to read procedures, documentation, computer displays, and equipment.