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Quality Assurance Associate

Date: Mar 16, 2019

Location: Carlsbad, CA, CA, US

Company: Glanbia

Quality Assurance Associate

Job Description Revised: January 2018

 

Reports To:                          Senior Quality Assurance Manager       

Department:                        Quality Assurance

Location:                              Carlsbad, CA

Pay Status:                           Non-Exempt

 

Job Summary

The Quality Assurance (QA) Associate is responsible for supporting the implementation of Quality Systems across the GNNA network. This individual will operate in a fast-paced, dynamic environment and is expected to manage multiple tasks on a tight timeline to meet customer requests.

Essential Functions and Responsibilities (not restrictive)

 

  • Drive resolution of product quality customer complaints and internal non-conformance events, ensuring positive resolution to customer.
  • Perform root-cause analysis and other problem solving activities to identify effective corrective and preventive actions and process improvements.
  • Create and revise technical documents including Standard Operating Procedures, Specifications, MSDS, Allergen statements, GMO Statements, Irradiation/ETO statements, etc.
  • Create Standard Operating Procedures to support Quality Systems.
  • Support customer and external audits. Ensure audit findings are addressed and resolved.
  • Support the establishment and implementation of quality metrics (process capability, control charts, measurement quality) for monitoring system effectiveness and for enabling sound product quality decisions.
  • Support Manufacturing QA personnel by performing real-time audits of production areas.
  • Address non-conformances in Manufacturing.
  • Perform verification / validation activities associated with the SQF system.
  • Follow the Deficient Material Process to ensure timely disposition of materials on hold. This process includes the following responsibilities.
  • Tracking MDR (Material Deficiency Reports)
  • Communicating with other departments to facilitate inspection and disposition.
  • Manage blocked stock in SAP system to ensure timely disposition of ingredients on hold.
  • Assist with Document Control, Change Control, CAPA and other Quality Systems tracking/trending.
  • Regular attendance is an essential function of this position.

 

Additional Functions

 

  • Perform other duties as assigned.

Performance Indicators

1.

2.

3.

4.

5.

6.

Ensure no MDR materials exceed 30 days in blocked stock.

Timely completion of MDR documentation.

Retention sample put away on a regular frequency.

Timely completion of Quality System issue escalation.

Timely completion of CRM responses and customer complaints. Meet department KPIs.

Ensure that verification and validation activities are completed.

Qualification & Experience Requirements

Education, Training:

  • BS/BA degree in Engineering, Chemistry, Biology or Food Science preferred.

Experience Required:

  • At least 5 years in a related role (preferred).
  • Exposure to audits (performing, conducting, participating).
  • Quality Systems exposure (Document Control, Change Control, NCRs, CAPA, etc.)

Knowledge, Skills, Abilities:

  • Good verbal and written communication skills
  • Ability to work with minimal supervision while remaining productive at all times
  • Ability to stay positive and calm in difficult and/or trying circumstances
  • Ability to effectively interact with all levels of personnel
  • Ability to write routine reports and correspondence
  • Must be assertive and be able to enforce procedures and call out deviations appropriately
  • Must have excellent problem solving skills
  • Must be able to follow written SOP’s / work instructions
  • Must be able to work in a team environment and work to resolve issues
  • Must be results-oriented and strive to meet team and organizational goals
  • Must be able to work flexible hours to include daily overtime and some weekends

Language, Computer &   Numeracy:

  • Proficiency in spoken and written English 
  • Strong SAP knowledge
  • Proficient with MS Word, Excel, Outlook, PowerPoint and SharePoint.

Travel Requirements

N/A

Typical Physical Activity

Physical Demands

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

 

Physcial Requirements

  • Must be able to lift and carry items weighing up to 20 pounds.
  • Manual dexterity sufficient to reach/handle items, works with the fingers, and perceives attributes of objects and materials.
  • Involves moderate physical activity performing non-strenuous daily activities of a primarily administrative nature.
  • Should be able to identify and distinguish colors, see clearly at 20 inches or closer and 20 feet or more, observe an area that can be seen up and down or to the left and right while eyes are fixed on a given point, judge distances and spatial relationships, and adjust the eye to bring an object into sharp focus.

Typical Environmental Conditions

  • May be exposed to moderate noise levels (i.e. office equipment, light traffic).
  • May be exposed to moderate to high noise levels (i.e. production equipment, forklifts, heavy traffic).
  • May be exposed to humidity, intense heat and cold, outdoor weather conditions, and fumes and toxic chemicals.
  • May work in areas with mechanical moving parts, above ground with risk of fall, or areas with risk of electrical shock.


Nearest Major Market: San Diego