Associate I, EM

About the role

The Environmental Monitoring (EM) Associate I is responsible for the monitoring of biological and airborne particulate levels in clean room environments for the purpose of preparation, compounding, and production of sterile injectable drug and drug products. The EM Associate will be trained on proper aseptic behavior, sanitization processes, and donning of sterile gowns. Associates will be required to have an aptitude for reading detailed procedures, clear documentation practices, and operating several environmental software applications; thus, digital literacy is highly encouraged for this position. Additionally, EM Associates will need adequate dexterity to don sterile gowns, requiring a level of coordination to balance while ensuring garments control while dressing. Additional responsibilities will include the collection of test samples aseptically, preparation of tools, equipment, and supplies which will be used in a clean room setting, and aseptic observations of aseptic technique.

Training requirements (first six months)

• Environmental and Product Sampling: Collect environmental and product samples within ISO 8 cleanroom environments during extended shifts (8, 10, or 12 hours). Perform gown sampling, area clearance, and product sampling in accordance with departmental procedures and GMP standards.
• Monitoring Equipment and Software Use: Operate environmental monitoring and testing equipment, including associated software applications such as MODA, to compile and manage sample data. Maintain equipment readiness and report any issues or deviations promptly.
• Preparation and Sterilization of Supplies: Prepare and organize sampling supplies including totes, labels, documents, tubing, and equipment. Operate autoclaves to sterilize materials and ensure readiness for sampling activities.
• Sample Processing and Incubation: Perform verification and incubation of environmental samples. Ensure proper documentation and traceability throughout the sample lifecycle.
• Documentation and Data Integrity: Accurately enter and verify sample data using MODA and other EM systems. Maintain high standards of data integrity and completeness in all records and observational memos.
• SOP Compliance and Training: Read, understand, and follow applicable SOPs and departmental protocols. Maintain current SOP training status and complete all required modules within the first six months.
• Aseptic Gowning Certification: Obtain and maintain aseptic gowning certification for entry into controlled environments. Demonstrate proper gowning technique and compliance with badge access protocols.
• Support for Requalification and Media Fill Activities: Assist in requalification sampling and media fill qualification processes as directed. Ensure sampling accuracy and adherence to procedural requirements.
• Cleanroom Entry and Alarm Response: Follow badge access protocols for smock and coverall use in designated areas. Respond appropriately to BAS user alarms and maintain situational awareness in cleanroom environments.

Qualifications

• HS Diploma required; AA degree preferred
• Previous work experience with strong work ethic (some overtime would be required)
• Minimum 1-year pharmaceutical or laboratory experience desired
• Knowledge of cGMP's, operation of autoclaves, aseptic technique, and basic computer skills desired
• Must be able to read and understand directions dictated in procedures with little to no assistance
• Write clear and accurate memos using correct spelling, punctuation and grammar
• Understand aseptic processing concepts and apply those concepts to job tasks and evaluation of situations
• MS Word, Excel Software Aptitude
• Ability to work with computer and tablets
• Mechanical Aptitude
• Manual Dexterity
• Must communicate clearly with other departments on Environmental Monitoring and other quality issues
• Must be able to work closely with other production, validation and maintenance/engineering personnel as well as members of the EM Lab
• Must be willing and able to ask appropriate questions in order to investigate situations surrounding environmental issues
• Must be able to use available information to make simple decisions on environmental issues and who to contact in these cases. Will usually be expected to ask the supervisor/specialist to confirm/negate the proposed decision
• Handle multiple tasks with minimum supervision and set priorities based on department priorities
• Evaluate situations involving processes and quality and make appropriate decisions under supervisor guidance
• Handle continual change in schedules, processes and procedures
• The employee must have the ability to learn the involved factors and evaluate situations. In most cases, recommendations made by the employee will be reviewed by the supervisor/specialist prior to implementation
• The employee must work independently and follow procedures accurately without close supervision, take responsibility for completing job tasks, following procedures and proper reporting of any deviations to procedure and be accountable for the accuracy of work performed
• Environmental Monitoring results are a requirement for product release. Therefore, work has to be completed and reported correctly and completely. Any deviation may have dramatic impact on product release. Procedures must be followed and any deviations must be reported and handled appropriately

Schedule

Weekday Days – Monday-Wednesday + every other Thursday 6am-6pm. On Site, Full-Time.

Pay and benefits

Hiring Wage: $20.75 – $25.91 + 2.5% shift differential, with opportunities for growth, promotion, and annual raises. Benefits begin on day one and include: Medical, Dental & Vision coverage; Flexible Spending Accounts (FSA) & Health Savings Accounts (HSA); Life & AD&D Insurance; Short-Term & Long-Term Disability Insurance; and Employee Assistance Program.