Technician, Quality Control 3 (SIAL) in Verona, WI at Apex Life Sciences

Date Posted: 5/10/2018

Job Snapshot

Job Description


Description:

Raw Material Sampling Technician 

Summary: 
This position’s primary function is raw material sampling. This entails collecting sample quantities from solid and liquid bulk containers while utilizing proper safety procedures and personal protective equipment. Bulk containers can range from 100mL bottle to 200L drum quantities. This position also requires the use of inventory management software that the technician will use daily as part of the sampling documentation process. 

PURPOSE OF THE POSITION 
The Raw Material Sampling Technician is responsible for the routine analysis of samples and all related paperwork. Analysis involves the use of HPLC, GC, KF, and IR among other tests and instruments. The position is also responsible for assisting with writing or revising standard operating procedures including raw material, intermediate, and final product specifications. Other responsibilities may include preparation of reagents, mobile phases, or other laboratory solutions, verification and/or qualification of instrumentation, participation in process improvement initiatives. Maintain a clean and safe working environment, and support the department in maintaining the laboratory in an audit ready state. The Technician, Quality Control 3 position will require a willingness to contribute to the overall success of the company by assisting in many areas beyond specific job duties. 

ESSENTIAL JOB FUNCTIONS 

  • Work on problems of moderate scope and exercise judgment within defined procedures and practices to determine appropriate action. Obtain assistance from supervisor or more experienced staff when needed. 
  • Analytically test raw materials or other analyses as assigned. Testing will involve the use of HPLC, GC, KF, automatic titrators, and IR among other tests and instruments. 
  • Participate in OOS investigations via testing and good documentation. 
  • Perform requalification of reference standards, and maintain reference standard inventory/documentation. 
  • Write and revise SOPs including raw material, intermediate, and final product specifications. 
  • Document testing properly and timely, including keeping laboratory notebooks accurate and up to date. 
  • Demonstrate proper laboratory techniques. 
  • Work cooperatively within the QC department and with other departments to achieve project goals. 
  • Work in compliance with effective procedures and regulatory requirements outlined in ICH Q7 and 21 CFR Parts 11, 210 and 211 as applicable 
  • Work in a safe manner and maintain the cleanliness of the work environment. 
  • Work in accordance with FDA, OSHA, EPA, DNR, DOT, and other regulatory agency guidelines. 



BASIC QUALIFICATIONS 
Education: 
Associate Degree in Chemistry or related biological sciences. 

Knowledge and Skills: 
Excellent written and verbal communication skills, as well as excellent documentation practices. Ability to work in a team environment. Ability to work in analytical testing labs with hazardous and toxic chemicals. 

Environmental conditions:

Work near moving mechanical parts. Frequently required to wear appropriate protective gear (hard hats, lab coats, safety glasses/goggles, chemical resistant suits, gloves, safety shoes) and other personal protective equipment “PPE” to protect from toxic or corrosive chemicals in the forms of liquids, solids, vapors, or airborne particles. Must be willing to work with highly potent/hazardous materials requiring the use of proper PPE, which could include half/full face respirators, Saranex and/or Tyvek suits with powered respiration. 



Physical requirements:

Regularly required to sit, stand, walk, reach above the shoulder, stoop, kneel, twist, crouch, or crawl for extended periods of time. Must occasionally lift and/or move up to 50 pounds unassisted and be capable of pushing and pulling heavy materials to complete assignments. May be required to lift more poundage with assistance. Must be able to speak, hear, taste, and smell. Specific vision requirements include close vision, distance vision, color vision, peripheral vision, depth vision, and the ability to adjust focus. Regularly use phones, computers, computer monitors, and all office/laboratory equipment. Required to type at a computer keyboard and have the ability to read CRTs/computer monitors.