Quality Assurance Assistant

SnugZ USA • West Jordan, UT

2d • $19 - $23 • Onsite

About The Position

The Quality Assurance Assistant supports SnugZ USA’s Quality Unit in maintaining accurate, complete, inspection-ready records for an FDA-regulated manufacturing facility. Reporting to the QA Manager, the role reviews batch records, logbooks, and quality forms for completeness and Good Documentation Practices; performs audit trail reviews after training and qualification; coordinates product and material sample testing with outside laboratories; and supports the release of approved materials to inventory. It is intended for a detail-oriented person interested in developing a career in quality assurance.

The position also supports production-floor checks, sample and retain-library management, incoming material documentation, document control, CAPA and deviation tracking, audit and inspection readiness, training records, supplier documentation, and quality metrics. Administrative support and other projects may also be assigned.

Work is primarily on-site in manufacturing, filling, packaging, warehouse, and laboratory areas, with some time in an office. The employee must follow applicable gowning and PPE requirements and may encounter cleaning agents, alcohol-based and flammable materials, and moderate manufacturing noise. The role involves standing and walking for extended periods, reaching, bending, and moving through work areas, and occasionally lifting and carrying up to 55 pounds. Occasional extended hours or schedule flexibility may be needed; travel is minimal.

Requirements

• High school diploma or equivalent.
• Strong attention to detail, including the ability to notice missing dates or mismatched lot numbers.
• Ability to follow written procedures exactly and willingness to complete qualification training.
• Excellent organizational and time-management skills.
• Proficiency with Microsoft Office, including Excel, Word, and Outlook.
• Clear written and verbal communication skills, including the ability to explain documentation errors constructively.
• Ability to handle confidential information with discretion.
• Ability to stand and walk for extended periods; reach, bend, and move throughout warehouse and production areas; and occasionally lift and carry up to 55 pounds.
• Ability to follow gowning and PPE requirements in production and laboratory areas.

Nice To Haves

• Associate's or bachelor's degree in Chemistry, Biology, Life Sciences, Regulatory Affairs, Industrial/Manufacturing Engineering, Business, or a related field.
• One to two years of experience in a regulated environment, such as drug, dietary supplement, food, or cosmetic manufacturing, or a laboratory.
• Coursework or experience with cGMP, FDA regulations (21 CFR Parts 210/211), ISO standards, or quality systems.
• Laboratory coursework or experience with sample handling.
• Experience with document management systems, ERP systems, or electronic QMS software.
• Bilingual English/Spanish.

Responsibilities

• Review executed batch records before release for completeness and GDP, including line clearance documentation, in-process check entries, yield calculations, and references to related deviations.
• Review logbooks and QA forms for completeness, accuracy, and GDP.
• Return documentation errors to the originator for correction and track corrections to closure.
• After training and qualification, perform electronic-system audit trail reviews according to procedure and escalate anomalies to the QA Manager.
• Conduct periodic production-floor walkthroughs to check that equipment logbooks and cleaning logs are current and equipment status tags are accurate.
• Verify that equipment calibration and preventive maintenance are not past due, and escalate discrepancies to the QA Manager.
• Pull, label, package, and ship product, raw material, and stability samples to third-party testing laboratories.
• Complete chain-of-custody forms, sample submission paperwork, and shipping logs.
• Track samples through shipment and receipt of results, and follow up with laboratories about turnaround times.
• Log incoming Certificates of Analysis and test results, and route them to QA for review.
• Help maintain the retain sample library, including inventory, labeling, and storage conditions.
• Compile incoming material documentation for QA review.
• After QA approval of a material, apply appropriate status labels and notify Inventory that the material is ready to move into inventory.
• Organize, file, scan, and retrieve controlled documents and records in paper and electronic formats.
• Help track SOP revisions, document approvals, and periodic reviews; verify current versions are in use and obsolete versions are archived.
• Track CAPAs, deviations, and other investigations, and prepare status reports for management.
• Assist with preparation for internal audits, customer audits, and regulatory inspections by gathering records, building binders, and maintaining request logs.
• Help maintain training records and training matrices for production and quality staff.
• Support supplier documentation files, including questionnaires, certifications, and specifications.
• Help maintain quality metrics trackers and spreadsheets.
• Provide administrative support to the Quality & Compliance team, including scheduling meetings, taking notes, and tracking action items.
• Maintain shared drives, trackers, and filing systems.
• Take on other projects as assigned.

Benefits

• Competitive hourly pay and benefits package.
• Hands-on experience in quality assurance within an FDA-regulated manufacturing environment.
• Training in cGMP, Good Documentation Practices, CAPA management, and audit readiness.
• Mentorship from experienced quality and compliance professionals, with room to grow within the Quality Unit.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED