Regulatory Quality Process Specialist

MeriCal®; Anaheim (CA); On-site; USD 72,000 - 80,000; Full time

Benefits offered by this job

No-cost vision insurance

Employer-paid life insurance

Paid holidays

Generous paid time off

Sick leave

Employee assistance program

Wellness program

Medical and dental plans

401(k) matching

Job summary

MeriCal is seeking a Quality Process Compliance Specialist to ensure cGMP compliance across manufacturing facilities in Southern California and Utah. You will drive QA programs, perform internal audits, and coordinate regulatory submissions while collaborating with R&D and Procurement to maintain high-quality standards.

Ideal candidates have 8+ years in FDA-regulated manufacturing, strong leadership, and proficiency in MS Office and Visio.

Qualifications

• Bachelor's degree in Food Science or equivalent is required.
• Minimum of 8 years in FDA regulated manufacturing environment.
• Working knowledge of FDA 21 CFR Parts 111, 117, 210 and 211.
• PCQI certification is a plus.

Responsibilities

• Ensure facilities operate per cGMP and internal Merical procedures.
• Lead product complaint investigations and track CAPAs.
• Perform internal audits and support regulatory inspections.
• Develop and update validation/verification protocols.
• Write, edit, and update company policies and procedures.

Skills

Critical thinking

Regulatory compliance

MS Office proficiency

English communication

Leadership / project mgmt

Education

Bachelor's Degree in Food Science or equivalent

Tools

MS Visio

Adobe Acrobat

Job description

MeriCal is seeking a Quality Process Compliance Specialist to ensure cGMP compliance across manufacturing facilities in Southern California and Utah. You will drive QA programs, perform internal audits, and coordinate regulatory submissions while collaborating with R&D and Procurement to maintain high-quality standards.

Ideal candidates have 8+ years in FDA-regulated manufacturing, strong leadership, and proficiency in MS Office and Visio.