Quality/Regulatory Support 1st Shift

4 weeks ago

Vista, United States FFP Full time
Job DescriptionJob Description

JOB SUMMARY: The Quality/Regulatory Support role is responsible for assisting in maintaining and improving the company's quality systems and ensuring compliance with regulatory requirements. This position will provide support to the Quality Manager and Regulatory Manager in implementing quality and regulatory initiatives.

KEY DUTIES AND RESPONSIBILITIES:

  • Assist in the development, implementation, and maintenance of the company's quality management system.
  • Support the Quality Manager and Regulatory Manager in maintaining compliance with applicable regulations and standards, such as FDA, SQF, and customer requirements.
  • Participate in internal and external audits to ensure compliance with quality standards and regulatory requirements.
  • Assist in the investigation and resolution of quality issues and customer complaints.
  • Coordinate and assist in the management of corrective and preventive actions (CAPAs).
  • Conduct internal quality and regulatory training sessions for employees.
  • Assist in the development and maintenance of quality and regulatory documentation, including policies, procedures, work instructions, and forms.
  • Provide support in conducting risk assessments and implementing risk mitigation strategies.
  • Assist in the management and tracking of quality and regulatory metrics.
  • Stay updated on new and changing quality and regulatory requirements, and communicate changes to relevant stakeholders.
  • Assist in maintaining and updating the company's product specifications and labeling information.
  • Support the Quality Manager and Regulatory Manager in customer audits and inspections.
  • Collaborate with cross-functional teams to drive continuous improvement in quality and regulatory processes.
  • Perform other duties as assigned by the Quality Manager or Regulatory Manager.
  • Follow GMP requirements and Quality Systems & Regulatory Compliance Department policies.
  • Other tasks as assigned.

Skills, Traits, & Competencies:

  • Attention to detail and ability to follow procedures
  • Strong analytical and problem-solving skills
  • Excellent communication and interpersonal skills
  • Ability to work effectively in a team environment
  • Proficient in MS Office applications
  • Knowledge of FDA regulations and quality standards (e.g., SQF) preferred
  • Experience in food industry quality and regulatory compliance preferred

Requirements

MINIMUM REQUIREMENTS:

  • A High School degree (or equivalent)
  • Working knowledge of Microsoft Office (including Word, Excel, Powerpoint)
  • Ability to create statistical charts
  • Extended hours of sitting and reading written documents
  • 1-3 years of experience in quality or regulatory support
  • Knowledge of quality management systems and regulatory requirements
  • Ability to work independently and manage multiple tasks
  • Strong organizational and time management skills
  • Some overtime maybe required

Benefits

  • Medical, Dental, Vision, and Prescription Drug Insurance on Day 1
  • Health and Wellness Incentives
  • 10 Days of PTO
  • 10 Paid Company Holidays
  • 5 Personal Days
  • 401(k)
  • Health Savings Account (H.S.A.)
  • Long-Term and Short-Term Disability
  • Life Insurance
  • Accidental Death & Dismemberment (AD&D)
  • Employee Assistance Program (EAP)

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