Quality Control Lab Technician

Ajinomoto Health & Nutrition North America, Inc.•Eddyville, IA

14h•Onsite

About The Position

This position is responsible for conducting chemical and physical laboratory tests and analysis on products and raw materials, making judgments on quality, reporting results, and assisting with special projects in accordance with GMP and safe food/safe feed policies. Analysis includes chemical, physical, and microbiological testing of raw materials in process and final product in compliance with all ISO standards. This position supports product quality, regulatory compliance, and continuous improvement initiatives through accurate laboratory testing, documentation, and equipment maintenance.

Requirements

High School Diploma or Equivalent required
2 years post-secondary education in Chemistry or Biology or other related Science or 1+ years relevant experience in a Laboratory environment required.
Experience with analytical instrumentation and laboratory software systems required.
Ability to work in team environment
Excellent oral, written and computer communication skills
Computer knowledge (i.e., Microsoft Office)
Strong attention to detail and problem-solving skills
Ability to use applicable software programs as related to laboratory instrumentation
Must be willing to work overtime as needed
Understanding of cGMP, GLP, FDA, and ICH regulatory requirements
Ability to interpret specifications, procedures, and test methods
Knowledge of analytical chemistry and laboratory techniques
Critical thinking and the ability to concentrate/focus on tasks for extended periods of time
Use of various lab equipment, such as HPLCs, Auto-titrators, Spectrophotometer, Dissolution instruments, FTIR, Polarimeter, pH instrument, ROTAP Sieve Shaker dependent on work location

Responsibilities

Utilize safe work habits and follow all policies and procedures
Make sound decisions while not compromising safety, environmental or quality standards
Turn in any hazards as they are identified during work hours to get them corrected as soon as possible
Know and understand all QA related issues including the QA policies and procedures that affect the role; know the location of and comply with all job instructions
Attend regularly scheduled training sessions to stay current on all compliance initiatives
Maintain a clean lab environment while operating lab equipment & perform necessary calibrations on lab equipment
Assist the Quality Assurance team with other duties as needed
Follow all applicable GMP, GLP, FDA, USP, EP, and company quality requirements
Adhere to Standard Operating Procedures (SOPs), work instructions, and safety procedures
Participate in internal audits, regulatory inspections, and laboratory assessments as required
Support change controls, deviations, CAPAs, method validations, and method transfers
Complete training for QMSRM items (if applicable)
Analyze raw materials, in-process samples, final product samples, and other samples to determine chemical and physical characteristics and evaluate for conformity.
Prepare chemical solutions, reagents, media, samples, and standards for use in analyzing materials dependent upon work lab location
Confirm incoming samples are properly labeled and that the correct tests have been requested
Accurately record all test data and perform required calculations
Maintain accurate written records; organize and maintain current database as well as hardcopy files of all analysis results when applicable in compliance with ALCOA+ data integrity principles
Review test results and supporting documentation for completeness and accuracy
Ensure proper archival and retention of laboratory records
Maintain confidentiality concerning all methods, analyses and results including notebooks, data graph, charts, and all hardcopies of pertinent material
Follow procedures as written for each test performed and perform procedural changes in accordance with policies
Investigate out-of-specification (OOS), out-of-trend (OOT), and atypical results as assigned
Calibrate, operate, maintain, perform routine maintenance, and troubleshoot laboratory equipment such as HPLC, GC, Spectrophotometer, Auto-titrators, dissolution instruments, pH meters, FTIR, Polarimeter, Sieve shakers, Humidity Chamber, etc.
Assist in ordering lab supplies (as needed)
Implement and organize files of all documents, samples, and other pertinent records
Collaborate with other departments within the company to accomplish tasks/goals
Suggest/implement process improvement, cost down, or best practice ideas
Continually strive for increasing processing efficiencies
Complete 5S activities to keep the work area clean and organized following GMP guidelines
Support laboratory investigations and special projects
Identify opportunities to improve laboratory efficiency, compliance, and performance