Environmental Control Analyst II

Use Your Power for Purpose Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is crucial to ensuring customers and patients receive the medicines they need, precisely when they need them. By collaborating with our forward-thinking engineering team, you'll play a key role in accelerating the delivery of medicines to the world. What You Will Achieve In this role, you will: The incumbent is a member of the Quality Environmental Control (EC) Laboratory team. Under the supervision of the Environmental Monitoring (EM) Section Manager, and designated EM Shift Team Leader(s), the incumbent will be responsible for the collection, analysis, and inspection of manufacturing environmental conditions and materials according to Standard Operating Procedures (SOPs). Samples can include both physical and microbiological, air, surface, and water system products, as well as commodity items. In addition, the incumbent shall be responsible for both physical and microbiological, collection and analysis of pharmaceutical waters, raw materials, active pharmaceutical ingredients (APIs), and finished products according to Standard Operating Procedures (SOPs). Assays to be performed will be qualitative, quantitative, and investigational in nature and are performed in compliance with USP, FDA, other regulatory body requirements, Pfizer SOPs, and approved license requirements. Aseptic gowning practices will also be adhered to for the performance of activities as required. Results are compared with specifications, documented as per data integrity regulations, and incumbent is responsible for providing communication of all process and specification deviations. Incumbent has working knowledge of EM, microorganism handling, aseptic technique, and quality concepts as to perform routine assignments with minimal supervision. Additional responsibility may include performing data trending activities and assisting with metrics reporting, as well as initiating and developing project plans for continuous improvements within the laboratory Collecting Samples      Conducts routine environmental monitoring sampling within the laboratory and manufacturing areas in addition to collecting commodity and manufacturing material samples. Sample types include both physical and microbiological for the purpose of further quality analysis. Aseptic technique will be utilized for sample collection as required per supplied standard operating procedures.  Conducts Assays     Accurately performs routine environmental monitoring analysis of supplied samples according to provided standard operating procedures. Also, performs handling, weighing, and processing of active pharmaceutical ingredients (APIs) on a routine basis. May also conduct routine quality analysis of supplied samples according to provided standard operating procedures as needed. Communicate effectively all basic technical issues, atypical or out-of-specifications test results, instrument malfunctions and methodology problems as they occur. May participate in active investigational analyses as well.  Analyses Results      Accountable for the accuracy and validity of testing results. Examines processed samples, both qualitatively and quantitatively, for the purpose of result and observation recording. Assists in data trending, analysis, and interpretation activities. Maintains accurate, complete, and legible records. Utilizes Laboratory Information Management Systems or other electronic record systems.   Safety Practices      Contributes to the housekeeping and cleaning of the laboratory areas. Safely handles/disposes of chemicals, biological agents, and waste. Comply with all Safety, Environmental, and Security policies as required. Communicates all safety concerns, incidents, and events as they occur.  Laboratory Support and Teamwork   Participates as a contributing member of the laboratory team in