Environmental Control Analyst II at Pfizer in United States - North Carolina - Rocky Mount

Job description

• Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients.

Responsibilities

• 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 sharing the performance of sample collection, testing, and general responsibilities. Performs data review of peers. Work with peers to ensure all lab results are completed in a timely manner and are completed with a high level of quality. Supports mentorship and leadership of new staff as needed. Has opportunity to participate in non-routine activities/projects to support the team goals. May initiate and develop project plans for the purpose of continuous improvement within the department. Learns to analyze and interpret project/study/investigation results and findings. Learns to determine next steps under guidance of supervisor and in compliance with applicable regulations; carries out technical and administrative duties as assigned.

Requirements

• Applicant must have High School Diploma or GED and 6 years of experience; OR an Associate's degree with 4 years of experience; OR a Bachelor's degree (preferably in Chemistry or other related Science) with 2 years of experience.
• Knowledge of basic microbiology, aseptic practices and/or environmental monitoring principles.
• Skills training in effective laboratory testing methods and computerized record keeping.
• Cleanroom Gowning and sampling experience - Aseptic practices

Skills

Required

• Knowledge of basic microbiology
• Aseptic practices
• Environmental monitoring principles
• Laboratory testing methods
• Computerized record keeping
• Data integrity regulations

Benefits

• The salary for this position ranges from $23.40 to $39.01 per hour. In addition, this position offers eligibility for overtime, weekend, holiday and other pay premiums depending on the work schedule and the Company’s policies. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided applies only to the United States - North Carolina - Rocky Mount location.