R&D Quality Associate

Job Description Created March 2020

Revision 1

Supervisor’s Title:           Contract Manufacturing QA Manager          

Department:                     Quality

Exempt Status:                 Exempt (Hourly)

 

Job Summary

Support the development, execution, and adherence of quality assurance processes for Glanbia Nutritionals to ensure compliance with regulatory, customer, and internal Glanbia expectations.

Essential Functions

• Act as first Quality point of contact for both the R&D Twin Falls site and the Cheese Innovation Center (CIC)
• Perform duties associated with the R&D facility and CIC facility Environmental Monitoring Program – pathogen swabs, water testing, and air sampling.
• Maintain PEM records, and provide monthly updates to R&D and CIC personnel on findings
• Audit processing records for CIC, and provide monthly reports and trainings on any Food Safety matters
• Become the R&D facility representative for Food Safety Modernization Act (FSMA) compliance and assist with annual and new hire trainings in this regard.
• Review and maintain the R&D facility Traceability Program, including TRAC Log and Package Log oversight
• Support R&D issues related to the SAP database and generating Certificates of Analysis (COAs)
• Verify product hold and release, as well as review product specifications using Genesis software
• Act as the initial QA point person for recalls and audits associated with R&D prototypes, and for ISDA inspections
• Create and maintain facility Standard Operating Procedures (SOP’s) for R&D equipment, including cleaning steps
• Perform mass balance reviews on new products developed by R&D to support internal specification sheets
• Assist the Contract Manufacturing QA Manager in moving internal spec sheets from preliminary to final status
• Assist with product sampling and shipment for QA and R&D projects. 
• Assist the Document Controls Specialist with uploading material documents into SharePoint, completing TraceGains questionnaires, and supporting other online document systems as needed. 
• Perform routine equipment calibrations and handle periodic split sample testing. 
• Act as the primary QA resource for other R&D sites as needed, under the guidance/direction of the SVP of R&D
• Contract Manufacturing QA Manager covers in R&D Quality Associate’s absence.

 

 

Additional Functions

• Perform other duties as assigned

 

Qualifications

• Associate degree from two-year college or university or a minimum of 2 years related experience
• Ability to respond to inquiries from scientists and other R&D personnel
• Ability to effectively present information and respond to questions from groups of scientists, product managers, and general Glanbia personnel.
• Participate in proactive team efforts to achieve departmental and company goals.

• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Proficient personal computer skills including electronic mail, record keeping, routine database activity, word processing, spreadsheet, graphics, etc.
• Ability to prioritize tasks and handle multiple projects simultaneously.
• Comply with all safety policies, practices, and procedures. Report all unsafe activities to supervisor and/or Human Resources

 

Typical Physical Activity

Physical Demands

• Regularly involves talking or listening, sitting, and the use of hands and fingers.
• Frequently involves reaching with hands and arms, standing and walking.
• Occasionally involves crouching, stooping, and/or kneeling.

Physical Requirements

• Must be able to lift and carry items weighing up to 50 pounds.
• Manual dexterity sufficient to reach/handle items, and work with the fingers.
• Involves light physical activity performing non-strenuous daily activities.
• Should be able to identify and d