Quality Assurance Analyst

Summary

Conducts internal audits, performs documentation control and reviews, helps investigate, and resolves quality issues, deviations, and customer complaints. Files, updates and creates QC, production and training records.

Essential Duties and Responsibilities

• Administer change control on company documents (SOPs), manufacturing (batch records) and regulatory procedures; ensure appropriate training is documented and only the most current revisions are in use.
• Review and audit production paperwork, batch records, QC inspections and sanitation reports for accuracy and completeness; calculate production yield and ensure compliance with established specification limits.
• Perform monthly internal GMP audits for all company departments (production, R&D, maintenance, etc.) and generate monthly GMP reports.
• Prepare rework, deviation, OOS, and NCMR documentation.
• Assist with investigation of product failures, customer complaints, and CAPA.
• Maintain Customer Complaint and Material Non‑Conformance files.
• Help coordinate employee training programs and oversee completeness of training records.
• Assist with material supplier qualification package reviews.
• Support equipment and instrument calibration and preventive maintenance programs.
• Assist in maintaining records of environmental and pest control programs.
• Report quality and/or food safety trends and potential issues to Quality Management; participate in investigations as necessary.
• Promote GMP, GDP, Food Safety, FDA, and company policies within QA/QC and production departments.
• Assist with preparation for FDA, NSF, ISO, Kosher, Halal, and other external audits.
• Perform other tasks and functions as assigned by the QC manager.

Qualifications

• Education: Bachelor’s degree (B.A.) in a scientific discipline from a four‑year college or university; alternatively, a high school diploma with 7+ years relevant experience/training.
• Experience: 2+ years in Quality Assurance or Quality Control; experience with batch record review, CAPA, customer complaint investigation, deviation and rework procedures; some experience on the floor of a food/dietary supplement manufacturing facility.
• Language Skills: Ability to write reports, business correspondence, and procedure manuals; read, analyze, and interpret technical procedures and government regulations; effectively present information and respond to questions.
• Mathematical Skills: Ability to add, subtract, multiply, divide using whole numbers, fractions, decimals; compute rates, ratios, percentages.
• Computer Skills: Knowledge of database, spreadsheet, and word‑processing software.
• Reasoning Ability: Define problems, collect data, establish facts, draw valid conclusions; apply common‑sense understanding to instructions; handle problems with abstract and concrete variables.

Physical Demands

The employee is frequently required to sit; use hands to finger, handle, or feel; and reach with hands and arms. Occasionally required to stand, walk, talk or hear, and taste or smell. Must occasionally lift and/or move up to 10 pounds. Vision requirements include close, distance, color, peripheral, depth perception, and ability to adjust focus.

Work Environment

The work environment frequently exposes the employee to fumes or airborne particles (herbal powders). Noise level is usually quiet.