Our Manufacturing & Supply Division is committed to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.
Our Quality Operations group ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers, we create an interdependent global manufacturing network committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
• Specific to Environmental and Utility Monitoring, the analyst will be responsible for maintaining the EM program to include the following:
• 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.
• In addition, the candidate selected for the Environmental Monitoring (EM) position will be responsible for reading EM Plates, TOC analysis, Conductivity, Gas Testing, LIMS, SAP, Trackwise, Investigations with GMP experience.
Quals--
Education Minimum Requirement:
• Associate’s degree preferably in a science field is required.
• Bachelor's degree in biological sciences is preferred.
Required Experience and 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 Experience and Skills:
• EM Sampling in a pharmaceutical setting (not EPA) with GMP experience.
• Quality Control, Quality Assurance and/or cGMP experience.
• Prior experience with GLIMS.
Important Notes:
• Shift: Ability to work 4 * 10-hr shift (Sun - Wed or Wed - Sat) 4pm- 2:30am EST
• Position: 1
Additional screenings:
Varicella titer and BCG screenings prior to start.
• The candidate must pass a varicella titer and clear BCG screenings prior to arriving for the first day on the job.
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 (Sun - Wed) 4pm- 2:30am EST.
Candidate should adhere to below requirements:
• Follow *** guidelines and safety guidelines.
• Follow guidelines to request time off.
• Wear business casual.
• Do not wear athletic or workout clothes.
• No makeup/no eyelash extensions/ no jewelry /no long nails/no Nail polish.
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