Quality Assurance Analyst

About the role

The Quality Assurance (QA) position at Sunrider involves conducting internal audits, managing documentation control, investigating quality issues, and resolving customer complaints. Key responsibilities include administering change control on company documents, reviewing and auditing production paperwork, preparing Rework, Deviation, OOS, and NCMR documentation, assisting with CAPA investigations, and maintaining training records.

Responsibilities

• Administer the change control on company documents (SOPs), manufacturing (batch records) and regulatory procedures and ensure that appropriate training is documented and only the most current revisions are in use.
• Reviews and audits production paperwork, batch records, QC inspections and sanitation reports for accuracy and completeness, calculates production yield and ensures compliance with established specification limits.
• When necessary, perform Monthly Internal GMP audits for all company departments, including production, R&D, maintenance, etc. and generate monthly GMP reports.
• Prepare Rework, Deviation, OOS, and NCMR documentation.
• Aids in the investigation of product failure, customer complaints, and CAPA.
• Maintain Customer Complaint and Material Non-Conformance files.
• Help coordinate employees' training programs and oversee the completeness of employees' training records.
• Aid in the material supplier qualification package reviews.
• Help with the equipment and instruments, calibration, and preventive maintenance program.
• Aid in maintaining records of the environmental and pest control programs.
• Reports quality and/or food safety trends and potential issues to Quality management and participates in investigations as necessary.
• Promote GMP, GDP, Food Safety, FDA’s and company policies within QA/QC and production departments.
• Aid in preparation for FDA, NSF, ISO, Kosher, Halal, and other external audits.

Qualifications

• Bachelor's degree (B.A.) in a scientific discipline from four-year College or university.
• 2 + years of experience in Quality Assurance or Quality Control.
• Experience with batch record review, CAPA and customer complaints investigation, deviation and rework procedures are much desired.
• Some experience working on the floor of a food/dietary supplement manufacturing facility.

Skills

• Reasoning ability.
• Mathematical skills.
• Computer skills (Database software, Spreadsheet software, Word Processing software).

Benefits

Equal employment opportunity and reasonable accommodation for qualified individuals with disabilities are provided.

Pay

Salary range: $XX - $XXX per year.

Schedule

Full-time position, Monday through Friday, 8:00 AM - 4:30 PM.