Job Description

Responsibilities

• Collection and testing of qualified Utility systems including Clean Steam, WFI, and compressed gases.
• Execute environmental sampling of Classified Areas including active air sampling, surface sampling, and non-viable air sampling.
• Provide data entry, review and approval as required.
• Provide summaries of test results to appropriate personnel as needed.
• Compile and evaluate environmental data for adverse trends.
• Directly support Performance Qualification activities.
• Perform routine monitoring of Personnel.
• Compile and author Annual Reviews.
• Author and summarize Re-qualification, Performance Qualification, and Special Study protocols.
• Perform monthly and weekly sample accountability.
• Submit LIMS sample rejections.
• Equipment Calibration and Management.
• Filing data sheets and document control of logbooks.
• Other duties requested by Management.
• Reading EM Plates, TOC analysis, Conductivity, Gas Testing, LIMS, SAP, Trackwise, Investigations with GMP experience.

Qualifications

• Associate’s degree preferably in a science field is required.
• Bachelor's degree in biological sciences is preferred.

Required Skills

• At least 1 year of relevant post-degree work experience in Environmental Monitoring, Aseptic Manufacturing or Microbiological Laboratory Operations.
• Evidence of good oral and written communication skills (i.e., effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills).
• Attention to detail, flexibility and an awareness of production and attendant quality control problems.
• Basic understanding of GMPs and of regulatory requirements as they apply to the vaccine, sterile pharmaceutical or related fields.
• Ability to sit, stand and move within workspace for extended periods, ability to perform repetitive tasks including frequent hand to finger manipulations, grasping, pushing and pulling; ability to lift to 50 pounds.

Preferred Skills

• EM Sampling in a pharmaceutical setting (not EPA) with GMP experience.
• Quality Control, Quality Assurance and/or cGMP experience.
• Prior experience with GLIMS.

Training Period: During training period, flexibility is needed. Training could occur during day shift (8am-5pm EST) or during night from 4pm-10 pm EST through Monday-Friday. Training period can last for 8-12 weeks. Once training is completed, candidate will start with actual shift from (Wed-Sat) 4pm- 2:30am EST.

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