Environmental Monitoring Associate

The Company

Scorpius BioManufacturing is an innovation-driven contract research, development and biomanufacturing organization offering clients a customized, integrated, end-to-end solution for their large molecule discovery research, process and analytical method development, cGMP manufacturing, product characterization, release testing needs, and clinical trial support. Our approach enables us to forge collaborative client relationships that move beyond the traditional service outsourcing model into full product development collaborations.

POSITION SUMMARY

The Environmental Monitoring Associate will be responsible for performing routine and batch-related Environmental Monitoring in cleanrooms, laminar flow hoods, air and steam systems, and other controlled environments, following current Good Manufacturing Practices. The ideal candidate must be organized, self-motivated, and thrive in a fast-paced and dynamic biotech environment. She/he must be versatile and adapt to rapid change with a strong desire to make a significant impact.

KEY RESPONSIBILITIES 

• Perform Environmental Monitoring (EM) in an aseptic environment (batch, routine, gowning monitoring, and utility testing).
• Sampling and testing (TOC, pH, conductivity) of WFI and clean steam drops.
• Performs Weekly, Monthly, and Quarterly EM, and as needed.
• Performs viable air, non-viable particle counts, and contact surface testing.
• Completes all necessary documentation on GMP documents in real-time.
• Responsible for the accurate recording, review, and storage of laboratory data using electronic notebook system.
• Incubate and enumerate organisms on cultured media.
• Ensure Sample Retains are readily available for shipping with proper documentation. Prepare for shipping testing to contract labs for chemistry and microbiology samples.
• Provide EM support including review, tracking of EM of Microbiology results in support of product release. In conjunction with Quality Assurance, ensure timely completion and data review of routine and batch-related microbiological data.
• Assist with facility qualification and validation as required.
• Ensure proper equipment function, calibration, maintenance, and troubleshooting of laboratory equipment.
• Assist with the initiation of investigations/deviations and the determination of root causes analysis.
• Seeks continuous improvement within EM related activities.
• Initiates the review/revision of EM related Standard Operating Procedures (SOPs).
• Follow best practices, quality trends, and regulatory requirements.
• Follows Standard Operating Procedures designed to ensure quality in EM tasks, consistent with established standards.
• Ensures compliance with US Food, Drug & Cosmetic Act.
• Ensure QC supplies are inventoried and ordered to avoid stock-out.
• Operation of cGMP glasswasher and autoclave.

EDUCATION & EXPERIENCE

• Associate’s degree or Bachelor’s in Microbiology or closely related field, or equivalent combination of education and experience is required.
• A minimum experience of 1 year in the pharmaceutical and biopharmaceutical industry is preferred.

KNOWLEDGE & SKILLS

• Knowledge of regulatory guidance and industry best practices is preferred.
• Knowledge of quality management system records (MasterControl) and the ability to serve as a record owner are a plus.
• Knowledge of performing QC microbiological testing assays (sterility, microbial endotoxins, bioburden, etc.) is preferred.
• Knowledge of laboratory science and aseptic techniques principles.
• Strong verbal, written communication skills and computer skills are required.
• Must be goal-oriented, quality-conscientious, and customer-focused.
• Ability to read, understand, and follow work instructions and laboratory test methods.
• Ability to work independently and cooperatively on a team.

PHYSICAL REQUIREMENTS and working Environment

• Flexibility is required for working hours. Some weekend work may be needed and earlier or later start/finish times may also be required.
• Working conditions vary; work may be performed in but is not limited to the aseptic area, mechanical areas, and laboratory.
• Laboratory and cleanroom setting: Will be exposed to bio-hazardous materials, hazardous waste, and pharmaceuticals.