Quality Assurance Specialist - Bilingual

Quality Assurance Specialist

Overview:

The Quality Assurance Specialist will fill a key compliance position within a growing manufacturing company which produces under both FDA and USDA jurisdiction. The individual will act as the primary person to monitor food safety and quality during production, coordinate tasks among departments to identify, solve and prevent problems affecting product quality, maximize productivity, and comply with customer and regulatory requirements.

He/she will be reporting to QA manager.

Responsibilities:

This individual will responsible for inspection, audit, investigation, problem solving and in plant validation.

When needed, this person shall be able to perform sampling and lab testing to support decision making.

Standard Hours: 3:30 PM – 12:00 AM

Must be flexible for training on 1st shift 9:00 AM - 5:00 PM

1. Serves as ‘Quality on the floor’ at least 50% of the time, to assist and guide manufacturing area leads and employees of 2nd shift to comply with our internal food safety programs.

2. Support the QA department in protecting the safety, quality and efficacy of company products, ensure daily practices continues to comply with all regulatory and SQF requirements.

3. Audit cGMP and CCP compliance during production. Independently perform walkthroughs of all manufacturing areas to observe and evaluate production activities relative to food safety practices.

4. Audit quality control of raw materials, packaging components, labels, and finished products to ensure compliance with established specifications and regulatory standards.

5. Identify any deficiencies and provide proper notification to area management.

6. Prepare audit reports detailing the walkthrough findings and identify any follow up items that requires action.

7. Recommend CAPA's for continuous improvement, follow up with issues identified until being resolved.

8. Conduct investigating and correcting quality-related issues (including customer complaints) through collaboration with other departments.

9. Review Production Batch Records and other manufacturing-related documents to verify compliance and record keeping for all mandated manufacturing processes, quality checks, testing, sampling, and sanitation activities.

10. Responsible for hold and release of raw material, product and equipment for second shift

11. Make proactive recommendations and offering/presenting solutions to the Quality Systems & Regulatory Compliance Department Management to improve quality and work efficiency.

12. Share knowledge, skills and information with other personnel in the Quality Systems & Regulatory Compliance Department and across functional areas.

13. Assist in the implementation of policies, operating procedures, quality systems and programs which ensure proper testing, evaluation, inspection, and technical support in order to meet product quality standards.

14. Participate in all regulatory, third party and customer audits and inspections, and corrective action response.

15. Conduct trials for process improvement.

16. Conduct in plant validations.

17. Update and Maintain SOPs/SSOPs.

18. Collect and process QA lab samples when needed.

19. Other responsibilities as assigned.

Qualifications:

1. BS Degree Food Science, Food Safety, Food Engineering, Food Microbiology, Nutrition Science related; will consider lower degree with comparable experience.

2. 1-3 years experience working in a food manufacturing environment with some QA or QC responsibilities.

3. Must have strong knowledge of cGMP's in the food industry.

4. Must be bilingual English and Spanish.

5. Knowledge of SQF preferred.

6. Knowledge of HACCP, FSMA preferred.

7. Knowledge of FDA and USDA regulations preferred.

8. Knowledge of internal audit, pest control, allergen management, environment monitoring, cleaning & sanitation preferred.

9. Technical writing skills computer literate with proficiency in Word and Excel.

10. Ability to work collaboratively and productively with personnel in other departments.

11. Ability to communicate clearly and effectively both orally and in writing.

12. Self motivated, can perform expected task with minimal oversight.