Quality Assurance Specialist

4 weeks ago


Orange, California, United States MeriCal, LLC Full time
Job Overview

MeriCal, LLC is seeking a detail-driven Quality Assurance Specialist to uphold our high standards in dietary supplement manufacturing. This role offers the opportunity to manage critical quality assurance programs and documentation, conduct impactful employee training, and lead product quality investigations, all within a collaborative and innovation-focused environment.

About the Role:

  • Manage training records, SOPs, calibration logs, audits, and HACCP plans, ensuring accurate control and archiving.
  • Deliver new hire onboarding, annual cGMP training, and quality-related training for all staff.
  • Lead product complaint investigations, ensure timely closure, and track trends.
  • Oversee document and process changes, maintaining compliance across impacted areas.
  • Conduct internal audits and support state, federal, and third-party inspections.
  • Ensure supplier qualification and FSVP compliance under FDA standards.
  • Assist with FDA recalls, regulatory inspections, and customer certifications.
  • Track and report KPIs for complaints, CAPAs, audits, and training activities.

Requirements:

  • 3+ years of quality experience in industries regulated by 21 CFR Parts 111, 117, 210/211 (Part 111 experience preferred)
  • Strong project management skills, adept at leading cross-functional teams
  • Excellent communication skills in English, both verbal and written
  • Ability to work independently and prioritize in a fast-paced setting
  • Proficient in Microsoft Office and ERP systems (SAGE preferred)

About MeriCal:

MeriCal is a leading private-label and contract manufacturer of dietary supplements with over 90 years of industry expertise. Our commitment to innovation and quality has established us as a trusted partner in the health and wellness space. Our culture emphasizes collaboration, safety, and continuous improvement, offering an excellent environment to grow your career.

What It's Like to Work Here:

At MeriCal, we foster a team-oriented, fast-paced environment where employees work together to achieve excellence. Our team members share a positive attitude, problem-solving skills, and a dedication to high-quality production. You'll be part of a collaborative workforce focused on innovation, safety, and the pursuit of wellness.

Benefits:

  • No cost vision insurance, employer-paid life insurance, paid company holidays, generous paid time off benefits and sick time, employee assistance program, and a comprehensive wellness program
  • Affordable medical and dental insurance plans that fit the needs of you and your dependents
  • Outstanding supplemental benefits, including Accident, Critical Illness, Hospitalization indemnity plans, and pet insurance
  • Matching 401k plan and more


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