Quality Assurance Assistant

About SnugZ USA

SnugZ USA operates an FDA-registered manufacturing facility in West Jordan, Utah, where we manufacture, test, and release over-the-counter (OTC) drug and personal care products, including SPF lip balms, sunscreens, and hand sanitizers, under 21 CFR Parts 210 and 211. Our Quality Unit oversees these products from incoming materials through batch release and post-market complaint handling.

SnugZ USA is a private equity-backed company and a national supplier of branded consumer products, including drinkware, bags, and accessories, sold through a nationwide distributor network.

Position Summary

The Quality Assurance Assistant supports the Quality Unit by keeping our records accurate, complete, and inspection-ready. Reporting to the QA Manager, this person reviews batch records, logbooks, and quality forms for completeness and Good Documentation Practices (GDP); performs audit trail reviews once trained and qualified; coordinates product sample testing with outside laboratories; and supports the movement of approved materials into inventory. This role is a strong fit for a detail-oriented person who wants to build a career in quality assurance within an FDA-regulated environment.

Key Responsibilities

Documentation Review

• Review executed batch records before release for completeness and GDP, including line clearance documentation, in-process check entries, yield calculations, and references to any related deviations.

• Review logbooks and QA forms for completeness, accuracy, and GDP.

• Return documentation errors to the originator for correction, and track each correction to closure.

• Once trained and qualified, perform audit trail reviews of electronic systems according to procedure and escalate anomalies to the QA Manager.

Production Floor Checks

• Perform periodic walkthroughs to confirm that equipment logbooks and cleaning logs are current and that equipment status tags are accurate.

• Verify that equipment calibration and preventive maintenance are not past due, and escalate any discrepancies to the QA Manager.

Sample Management & Testing Coordination

• 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 from shipment through receipt of results, and follow up with labs on turnaround times.

• Log incoming Certificates of Analysis (COAs) and test results, and route them to QA for review.

• Help maintain the retain sample library, including inventory, labeling, and storage conditions.

Incoming Material Support

• Compile incoming material documentation for QA review.

• After QA approves a material, apply the appropriate status labels and notify the Inventory team that the material is ready to be moved to inventory.

Document Control Support

• Organize, file, scan, and retrieve controlled documents and records, both paper and electronic.

• Help track SOP revisions, document approvals, and periodic reviews.

• Verify that current document versions are in use and that obsolete versions are archived.

QA & Compliance Support

• Track the status of corrective and preventive actions (CAPAs), deviations, and other investigations, and prepare status reports for management.

• Assist in preparing 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.

Other Duties

• Provide administrative support to the Quality & Compliance team, such as scheduling meetings, taking notes, and tracking action items.

• Maintain shared drives, trackers, and filing systems.

• Take on other projects as assigned.

Qualifications

Required

• High school diploma or equivalent required.

• Strong attention to detail - Ability to notice a missing date or a mismatched lot number.

• Ability to follow written procedures exactly, and willingness to complete qualification training.

• Excellent organizational and time-management skills.

• Proficiency with Microsoft Office (Excel, Word, Outlook).

• Clear written and verbal communication skills, including the ability to explain documentation errors to originators constructively.

• Ability to handle confidential information with discretion.

Preferred

• Associate's or bachelor's degree in Chemistry, Biology, Life Sciences, Regulatory Affairs, Industrial/Manufacturing Engineering, Business, or a related field preferred

• [1–2] 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

Work Environment and Physical Requirements

• Work is performed primarily on-site in manufacturing, filling, packaging, warehouse, and laboratory areas, with the remainder in an office setting.

• Must follow gowning and PPE requirements in production and laboratory areas, such as safety glasses, gloves, hair and beard covers, and lab coats.

• Must be able to stand and walk for extended periods; reach, bend, and move throughout warehouse and production areas to perform sample handling, floor inspections, and material labeling. Must be able to occasionally lift and carry up to 55 pounds.

• Work involves exposure to cleaning agents, alcohol-based and flammable materials, and moderate noise from manufacturing equipment.

• Occasional extended hours or schedule flexibility may be needed to support validation runs, production schedule, and project deadlines.

• Travel is minimal, such as visits to suppliers or contract laboratories.

• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the role.

What We Offer

• [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, and room to grow within the Quality Unit.

Snugzusa LLC is an equal opportunity employer and is a supporter of diversity and inclusion. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.