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:

• The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• 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.

SUPERVISION:

• None

 
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.

Fresenius Medical Care maintains a drug-free workplace in accordance with applicable federal and state laws.