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QA Specialist II

Date: Jul 12, 2019

Location: Aurora, IL, US, 60504

Company: Glanbia

General Summary: Collaborative decision making across multiple functions; Management, Regulatory, Legal, Scientific Affairs, Procurement, Marketing, Innovation, laboratory and Quality on gathering essential regulatory, quality and food safety documentation’s as it pertains to Supplier, Raw Material, Packaging Material and Label Approval Processes.

 

Essential Functions:

  • Ability to uphold regulatory, company, and customer standards.
  • A high level of technical expertise, ownership and practical knowledge of all QA/regulatory programs.
  • Responsible for document management systems.
  • Write quality assurance policies and procedures.
  • Evaluate adequacy of quality assurance standards.
  • Thorough issue resolution in a timely manner.
  • Develop, recommend and monitor corrective and preventive actions.
  • Review and set-up for implementation of quality inspection plans.
  • Assure ongoing compliance with quality and industry regulatory requirements.
  • Support on-site audits conducted by external providers including state and federal FDA inspections.
  • Analyze data to identify areas for improvement in the quality system.
  • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
  • Prepare reports to communicate outcomes of quality activities.
  • Collect and compile statistical quality data via database.
  • Perform and execute risk management activities as it pertains to material and write supply chain preventive controls plans when there is a reasonable/foreseeable hazard.
  • Implement and monitor shelf life stability program.
  • Ratify and finalize specifications in a timely manner
  • Follow through with procurement to receive investigation results, actions planned, closure of actions that supplier is taking by requesting for objective evidence.
  • Draft and implement, and maintain master manufacturing records (MMR’s).
  • Perform finished product label reviews for compliance with MMR’s.
  • Investigate customer complaints and non-conformance issues.
  • Draft raw material and finished goods protocols.
  • Perform other duties as assigned.

 
Knowledge, Skills and Abilities: 

  • Knowledge of cGMPs, HACCP, HARPC and 21CFR 117 and 111 regulatory requirements.
  • Must have excellent interpersonal communication skills.
  • Knowledge or certification in ISO, NSF, or other certifying bodies.
  • Must be proficient in Word, Excel, and MS Office programs.

     

Decision Making/ Problem Solving:

  • Communication skills - verbal and written
  • Strong decision making skills
  • Data collection, management and analysis
  • Problem analysis and problem solving
  • Planning and organizing
  • Judgment
  • Customer service orientation
  • Teamwork
     
    Education/Experience:
  • Bachelor of Science degree in a relevant field of study (Food Science, Microbiology, etc.)
  • Experience in the food industry, particularly with health/supplement/nutritional food.
  • Experience with Standards of Procedure (development, writing, implementation and education).
  • Years of experience: 3-5 years
  • Strong computer skills including Microsoft Office and databases including programming
  • Specialized training in: PCQI & HACCP
  • Knowledge of tools, concepts and methodologies of QA
  • Experience with implementation of corrective action programs
     

PHYSICAL DEMANDS: (The work is classified as Light - Medium Physical Demand Level (PDL) by the US Dept. of Labor’s Dictionary of Occupational Titles.)

Frequencies: Occasional (1-33%); Frequent (34-66%); Continuous (67-100%)

 

Lifting Demands:

  • None

Postural Demands:

  • Sitting - Frequent

 

Equal Opportunity Employer: Disability/Veteran. We are an equal opportunity and affirmative action employer that does not discriminate and considers all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status


Nearest Major Market: Aurora
Nearest Secondary Market: Chicago