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.
Job Tags
Work experience placement, Monday to Friday, Shift work, Night shift, Day shift,