Apr 16, 2019

Quality Lab Specialist

  • Tate & Lyle
  • McIntosh, AL 36553, USA

Job Description

Quality Lab Specialist

Role Description                                 

 

ROLE PURPOSE

 

The Quality Lab Specialist ensures that all laboratory equipment is functioning properly, calibrations are current and all results are accurately reported within a timely manner to meet customer and business requirements.   This position works closely with plant operations in resolving day-to-day issues as well as establishing good control practices in the manufacturing environment.

 

MAIN ACCOUNTABILITIES

Lab Operations

  • Reviewing data for accuracy and reporting
  • Maintain training documentation and records, keeping SOPs current, and ensuring proper training of         new hires
  • Must have an intimate knowledge of equipment, instrumentation, and projects operating in the Lab
  • Interfaces with technical staff, e.g., Project Leaders, R&D, PC and others
  • Coordinates with vendors  to maintain lab equipment, ensuring that preventative maintenance is      performed
  • Investigates out of specification results
  • Coordinates and assists QA on investigations for complaints, deviations, and other lab and packaging issues
  • May function as a Lead on specific projects

Audits:

  • Preparation and participation in audits (such as BRC, customer, Kosher, and internal audits) 

 

Nonconforming Product Management and Investigation

  • Gathers data to investigate deviations and performs analysis on data.
  • Generate reports and analyze data for problem solving
  • Assist in Customer Complaint investigations
  • Execute traceability exercises as required

 

 

 

 

PERFORMANCE MEASURES

  • No major audit findings in the laboratory
  • No major safety finding in the laboratory
  • Current instrument and equipment calibrations
  • Laboratory equipment available to perform required testing.
  • Ensure regulatory compliance to Good Manufacturing Practices as defined by 21 CFR 117

 

 

COMPETENCIES, SKILLS, KNOWLEDGE, EXPERIENCE AND QUALIFICATIONS 

COMPETENCIES

  • Professional competence
  • Capacity for Teamwork
  • Good time management
  • Enthusiasm
  • Motivation and Engagement
  • Reliability 
  • Decision-making ability
  • Willingness to assume responsibility
  • Ability to problem solve

 

QUALIFICATIONS

  • BS in a science related field
  • Three to five years lab experience in a fast paced laboratory environment running release testing or time critical samples.
  • Ability to troubleshoot instrumentation
  • Understanding of Good Laboratory Practices

EXPERIENCE

  • Understanding of  cGMP and quality systems in a regulated environment
  • SOP writing
  • Protocol / validation / IQ,OQ,PQ writing and execution
  • Familiarity with LIMS systems and chromatography data collection systems (Labware LIMS and Empower a plus)
  • Theory, operation and troubleshooting of HPLC, GC, IC, ICP, FTIR. 
  • Microsoft products: Word, Excel, PowerPoint;  Visio is a plus
  • Understanding of Good Laboratory Practices

SKILLS / KNOWLEDGE

  • Excellent computer skills
  • A working knowledge of SAP and quality programs is preferred
  • Excellent organizational skills
  • Good Analytical Chemistry skills
  • English Language

 


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