Senior Quality Process & Compliance Specialist

Socket.dev; Anaheim (CA); On-site; USD 72,000 - 80,000; Full time

Benefits offered by this job

Vision insurance

Life insurance

Holidays

Paid time off

Sick leave

Employee assistance

Wellness program

Medical/dental plans

Pet insurance

401(k) matching

Job summary

MeriCal is hiring a Quality Process Compliance Specialist to ensure our facilities operate per cGMP and internal SOPs, with real-time documentation and regulatory adherence. You will drive internal audits, CAPA processes, and cross-functional collaboration with R&D and Procurement to maintain top-tier quality.

A strong background in FDA regulations and mentoring teams is essential. You will coordinate recall activities, supplier reviews, and training, while maintaining calibration programs and

Qualifications

• Bachelor's degree in Food Science or equivalent is required.
• Minimum 8 years in FDA-regulated manufacturing.
• Experience with FDA 21 CFR Parts 111, 117, 210/211 or related sections is preferred.
• PCQI certification is a plus.
• Strong leadership and cross-functional collaboration skills.

Responsibilities

• Ensure facilities operate per cGMP and Merical procedures; real-time recordkeeping.
• Lead product complaint investigations and CAPAs; ensure closure within 30 days.
• Coordinate internal audits and regulatory inspections across multiple sites.
• Develop and administer certification programs with R&D and Procurement.
• Review calibration results and maintain master calibration lists.
• Support FDA recall/withdrawals and supplier qualification reviews.
• Train personnel on procedures and regulatory requirements.
• Oversee change controls and validation/verification protocols.
• Prepare and update quality reports and annual product reviews.

Skills

Regulatory compliance

Attention to detail

Leadership

MS Office

Communication

Documentation

Education

Bachelor's Degree in Food Science or equivalent

Tools

MS Office

Visio

Adobe Acrobat

MS Teams

Job description

MeriCal is hiring a Quality Process Compliance Specialist to ensure our facilities operate per cGMP and internal SOPs, with real-time documentation and regulatory adherence. You will drive internal audits, CAPA processes, and cross-functional collaboration with R&D and Procurement to maintain top-tier quality.

A strong background in FDA regulations and mentoring teams is essential. You will coordinate recall activities, supplier reviews, and training, while maintaining calibration programs and