Lab Analyst I

Role Summary

The Laboratory Analyst I participates in a defined training curriculum to gain competency performing routine chemical, biological, and/or microbiological assays of engineering and/or commercial product raw materials, production bulk samples, finished product, environmental monitoring samples, process and cleaning validation samples, package samples, and components. The Analyst I works closely under the observation of a qualified trainer and supervision. The Analyst I gains competency in assays that are routine, qualitative, quantitative and investigational in nature and are performed in compliance with USP, FDA and other regulatory body requirements, Pfizer standard operating procedures, and approved license requirements. The Analyst I is responsible for preparing test solutions, setting up basic instrumentation, demonstrating instrument and method suitability of use, and calculating results. The Analyst I priorities are dictated by the Supervisor and/or Sr Analysts.

Responsibilities

• Perform basic chemical, biological, and/or microbiological assays of clinical and/or commercial product raw materials, production bulk samples, finished product, environmental monitoring samples, process and cleaning validation samples, package samples and components of increasing complexity as competency is demonstrated.
• Determine the validity and acceptability of the analytical results versus the regulatory requirements and escalate to management any discrepancies for immediate action.
• Recognize atypical or out-of-specification routine test results, instrument malfunctions and methodology problems and participate in the investigation to resolve and correct.
• Determine next steps associated with out of specification data under guidance of Sr Analyst and/or Supervisor.
• Perform routine instrument maintenance and calibration for intended methodology.
• Prepare analytical reference standards, reagents, test solutions, and sample preparations for required activities.

Qualifications

• Applicant must have a HS Diploma (or Equivalent) and 2 years of relevant experience.
• Excellent oral, written, and interpersonal communication skills with the ability to communicate obstacles and project status within functional group without prompting for updates.
• Basic knowledge and practical application of relevant analytical techniques – such as HPLC, Gas and Liquid Chromatography, UV/VIS, IR, microbiological testing and identification.

Additional Requirements

• Considerable concentration and some manual dexterity.
• Long periods of standing and sitting and significant walking.
• Regular lifting (less than 35 lbs.) and reaching may be required to retrieve chemicals, reagents, and samples.
• Extended time working at a computer.
• Maintains a clean and organized laboratory environment.
• Strict documentation requirements.
• Cooperates with other colleagues, departments, and sites.
• May require off-shift and weekends or may include on-call work.
• Lab environment with hazardous chemicals and/or biologically active materials.