Quality Coordinator

MeriCal•Anaheim, CA

About The Position

A Quality Assurance Coordinator supports the Quality Assurance and Quality Control Functions in maintaining compliance with applicable Good Manufacturing Practices (GMP), company procedures, customer requirements, and applicable FDA regulations, including 21 CFR Parts 111, 117, 210, and 211, as applicable. The position coordinates quality activities, maintains accurate and complete quality records, supports manufacturing and packaging operations, and assists with investigations, audits, deviations, complaints, CAPA, and continuous improvement initiatives.

Requirements

Minimum High School diploma.
3+ years of experience working in a QA/QC environment preferably in a dietary supplement environment.
Excellent verbal and written communication, understand instructions in English.
Proven track record with paperwork efficiency as it pertains to the QA/QC department.
Proficient with Microsoft Office Suite and related software.
ERP Systems (SAGE).
Must understand QA/QC instructions to process and procedures as it pertains to GMP's in a dietary supplement environment.
Strong written and verbal communication skills.
Ability to work independently with limited supervision.
Training in FDA Regulatory compliance 21 CFR Part 111, 210/211 Certified Quality GMPs.

Nice To Haves

Bachelor's Degree preferred.
Certificates of completion from ASQ, Train the Trainer Course, PCQI etc., a plus.

Responsibilities

Review manufacturing, packaging, labeling, and quality documentation for completeness, accuracy, traceability, and compliance with approved procedures.
Coordinate review and processing of Batch Production Records (BPRs), Master Manufacturing Records (MMRs), packaging records, label records, and associated quality documentation.
Support the Quality team with material review and disposition activities, including documentation of investigations, corrective actions, and final disposition decisions.
Support the Quality team in the qualification and approval of supplier and vendors, including collection and review of required quality documentation, specifications, certifications, questionnaires, and other qualification records.
Coordinate the receipt, inspection, status control, and documentation of components, packaging materials, labels, and other materials; assist Quality with material review, approval, quarantine rejection, and disposition in accordance with established GMP procedures.
Support manufacturing and packaging floor activities, including line clearance, documentation review, in-process inspections, sampling, and verification of compliance with approved procedures.
Assist with internal, customer, supplier, and regulatory audits by preparing documentation, coordinating requests, supporting audit logistics, and tracking audit observations and commitments to completion.
Maintain audit readiness by routinely reviewing quality records and identifying document gaps, recurring issues, and opportunities for improvement.
Support training activities by maintaining GMP and Quality training records and assisting with assignment and by tracking of required training.
Maintain accurate, organized, and readily retrievable Quality records in accordance with applicable record-retention requirements.
Participate in Quality investigations, root-cause analysis, risk assessments, and continuous improvement activities.
Escalate potential product quality, GMP, safety, documentation, or compliance issues to appropriate Quality personnel.
Promote a strong GMP and quality culture by working collaboratively with Manufacturing, Packaging, Warehouse, Laboratory, Maintenance, and other functional teams.