Quality Assurance Analyst

The Sunrider Corporation•Midlothian, TX

About The Position

The Quality Assurance Analyst conducts internal audits; controls and reviews documentation; helps investigate and resolve quality issues, deviations, and customer complaints; and files, updates, and creates QC, production, and training records. The role supports quality and food-safety programs in a food or dietary supplement manufacturing environment and may take on other duties as business needs dictate. The analyst administers document change control for SOPs, manufacturing batch records, and regulatory procedures, ensuring appropriate training is documented and current revisions are used. The role reviews production paperwork, batch records, QC inspections, and sanitation reports for accuracy and completeness; calculates production yield; and checks compliance with specifications. It may also perform monthly GMP audits across departments and prepare reports. Additional duties include preparing rework, deviation, OOS, and NCMR documentation; assisting with product-failure, customer-complaint, and CAPA investigations; maintaining complaint and material non-conformance files; coordinating training records; reviewing supplier qualification packages; supporting equipment calibration and preventive maintenance; and maintaining environmental and pest-control records. The analyst reports quality or food-safety trends and potential issues to Quality management, promotes GMP, GDP, food-safety, FDA, and company policies, and assists with external audits.

Requirements

Bachelor's degree in a scientific discipline from a four-year college or university, or a high school diploma with 7 or more years of relevant work experience and/or training.
At least 2 years of experience in Quality Assurance or Quality Control.
Some experience working on the floor of a food or dietary supplement manufacturing facility.
Ability to write reports, business correspondence, and procedure manuals; read, analyze, and interpret technical procedures and government regulations; and present information and respond to questions.
Ability to perform basic arithmetic and calculate rates, ratios, and percentages.
Knowledge of database, spreadsheet, and word-processing software.
Ability to define problems, collect data, establish facts, draw valid conclusions, follow instructions, and address problems involving abstract and concrete variables.

Nice To Haves

Experience with batch record review, CAPA and customer complaint investigations, deviation procedures, and rework procedures is much desired.

Responsibilities

Administer change control for company SOPs, manufacturing batch records, and regulatory procedures; ensure training is documented and current document 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 specification limits.
When necessary, perform monthly internal GMP audits across company departments and generate monthly GMP reports.
Prepare rework, deviation, OOS, and NCMR documentation.
Assist with investigations of product failures, customer complaints, and CAPA; maintain customer complaint and material non-conformance files.
Help coordinate employee training programs and oversee completion of employee training records.
Assist with reviews of material supplier qualification packages.
Help with equipment and instrument calibration and preventive maintenance programs.
Assist in maintaining environmental and pest-control program records.
Report quality and food-safety trends and potential issues to Quality management and 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.