Laboratory Scientist I

Purpose and Scope

Review and evaluate current test methods for improvements. Write and perform test method and laboratory equipment re-qualifications and validations. Write scientific reports and summaries. Perform testing supporting release product and special projects.

Principal Duties and Responsibilities

• Work on method improvement, and support management on any special projects.
• Assist laboratory management in training employees.
• Assist laboratory management in OOS investigations.
• Write reports and keep test methods up to date.
• Must be proficient in performing all applicable current test methods.
• As required, investigate new techniques to improve existing testing methods and laboratory practices.
• Keep familiar with established methods and techniques.
• Keep familiar with plant SOP's, policies and standards including cGMP, ISO, and safety standards.
• Maintain good documentation practices for all forms, protocol reports, and laboratory notebooks.
• Keep familiar with and practice current data integrity standards.
• Maintain proper GLP's and technique for handling laboratory reagents and instrumentation.
• Maintain proficiency in instrument and equipment operation, including maintenance.
• Work with and provide input to the lab supervisor and technicians on matters, regarding product issues and general lab performance.
• Act as laboratory liaison with other departments as required.
• Observe good housekeeping practices in compliance with FDA and ISO standards.
• May provide assistance to junior level staff with general tasks that require a better understanding of functions, as directed by immediate supervisor.
• May refer to senior level staff for assistance with higher level problems that may arise.
• Escalates issues to supervisor/manager for resolution, as deemed necessary.
• Assist with various projects as assigned by direct supervisor.
• Other duties as assigned.
• Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.

Physical Demands and Working Conditions

• Regularly required to use hands to perform various tasks and duties; talk or hear and personal protective equipment required may include: safety shoes, safety glasses, hearing protection, respirator, back or wrist brace, smock, hair net, shoe booties, face mask.
• Frequently required to stand; sit and reach with hands and arms.
• Occasionally required to walk; climb or balance; stoop, kneel, crouch, or crawl and smell.
• Must frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 100 pounds.
• Repetitive motion by knocking bubbles out of dialyzers, lifting stack of wet and dry dialyzers.

Education

Bachelor's Degree in Chemistry or Biological Science

Experience and Required Skills

• 2 - 5 years' of directly related work experience.
• Must have a working knowledge of GMPs/GLPs, ISO, FDA guidelines, USP and their applications.
• Some knowledge of statistical analysis and ANSI/ASQC sampling plans preferred.
• Proficient with PCs and Microsoft Office applications.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Strong oral and written communication skills.