Quality Process Compliance Lead (FDA-Regulated)

Merical,-LL; Anaheim (CA); On-site; USD 72,000 - 80,000; Full time

Benefits offered by this job

No-cost vision insurance

Life insurance

Paid holidays

Generous paid time off

Sick leave

Employee assistance program

Wellness program

401(k) matching

Job summary

MeriCal is seeking a Quality Process Compliance Specialist to ensure cGMP compliance and real-time documentation across manufacturing, QA, maintenance, and warehousing. You will drive regulatory adherence, maintain QA programs, and coordinate audits, CAPAs, and process improvements.

The role requires a Bachelor’s in Food Science, 8+ years in FDA-regulated environment, strong auditing skills, and expertise in 21 CFR Parts 111, 117, 210, 211. Competitive benefits and pay offered.

Qualifications

• Requires a Bachelor’s Degree in Food Science or equivalent.
• Minimum 8 years in FDA-regulated manufacturing environment.
• Knowledge of FDA 21 CFR Parts 111/117/210/211 and HACCP.
• Proficient in MS Office and Visio with good documentation skills.

Responsibilities

• Ensure facilities operate per cGMP and internal SOPs; maintain QA programs.
• Lead internal audits, investigations, CAPAs and changes; report KPI.
• Coordinate with departments to ensure compliance and timely records.
• Support regulatory inspections and supplier qualification activities.

Skills

Critical thinking

Attention to detail

Communication

Self-motivation

Education

Bachelor's Degree in Food Science

Tools

MS Office

Visio

Adobe Acrobat

Job description

MeriCal is seeking a Quality Process Compliance Specialist to ensure cGMP compliance and real-time documentation across manufacturing, QA, maintenance, and warehousing. You will drive regulatory adherence, maintain QA programs, and coordinate audits, CAPAs, and process improvements.

The role requires a Bachelor’s in Food Science, 8+ years in FDA-regulated environment, strong auditing skills, and expertise in 21 CFR Parts 111, 117, 210, 211. Competitive benefits and pay offered.