Quality Assurance Specialist

Quality Assurance Specialist

The Quality Assurance Specialist supports production quality in a regulated manufacturing environment and ensures strict compliance with established standards and procedures. This role focuses on documentation review, product release, changeover oversight, and issue escalation, rather than routine production line checks. The position plays a key part in launching and sustaining new product lines by establishing and reinforcing quality and sensory standards.

Responsibilities

• Create and manage work orders and complete all related documentation in alignment with the production schedule.
• Maintain product retains, including collection, tracking, organization, and secure storage.
• Issue deviations, document nonconformances, and partner with Quality Assurance to investigate and resolve issues.
• Address on-floor and quality control inspection concerns, including labeling accuracy, component placement, and overall product quality.
• Inspect and approve incoming components and evaluate questionable parts, escalating concerns when necessary.
• Establish sensory standards for finished goods and train production and quality staff on these standards.
• Review batch records for completeness and accuracy and provide second sign-off for product release.
• Complete changeover documentation for production runs to ensure proper line clearance and compliance with procedures.
• Maintain accurate quality records and tracking systems to support audits and continuous improvement initiatives.
• Drive continuous improvement by identifying quality issues, reinforcing standards, and recommending process enhancements.
• Perform inspections using tools such as micrometers, calipers, pin gauges, and placement gauges as required.
• Visually compare colors against established reference standards and identify color-coded labels, status tags, and chemical hazard warnings.
• Evaluate the appearance of raw materials and finished products to identify irregularities or deviations from established specifications.
• Detect and differentiate odors during evaluation of raw materials and finished products in accordance with applicable testing specifications, including identifying unexpected or out-of-specification odors.
• Collaborate effectively with production, quality, and R&D teams to support new product lines and ensure robust quality testing.
• Adapt to changing priorities and production schedules while maintaining high quality standards and meeting deadlines.

Essential Skills

• 1–3 years of quality assurance experience in a manufacturing or regulated environment.
• Direct experience in Quality Assurance activities such as reviewing documentation, managing product release, completing changeover documents, and serving as an escalation point when issues arise.
• Experience working with regulated products such as food, cosmetics, personal care, over-the-counter products, coatings, or similar environments.
• Working knowledge of FDA regulations, GMP (Good Manufacturing Practices), GDP (Good Documentation Practices), and quality systems.
• Experience using inspection tools including micrometers, calipers, pin gauges, and placement gauges.
• Strong attention to detail with the ability to identify deviations and maintain accurate documentation.
• Excellent organizational skills and the ability to prioritize and multitask in a dynamic production environment.
• Proficiency in Microsoft Word, Excel, and basic computer systems.
• Strong communication and interpersonal skills with a collaborative, team-oriented mindset.
• Ability to adapt to changing priorities and production schedules while maintaining compliance with quality standards.
• Ability to perform tasks requiring close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
• Ability to visually compare colors against reference standards and accurately identify color-coded labels, status tags, and hazard warnings.
• Ability to detect and differentiate odors during evaluation of raw materials and finished products, including identifying out-of-specification odors.
• Ability to visually evaluate the appearance of raw materials and finished products and identify irregularities or deviations from standards.

Additional Skills & Qualifications

• Associate or technical degree in a relevant field is preferred.
• Experience in environments such as food, pharmaceutical, cosmetics, chemical, or other regulated manufacturing sectors.
• Familiarity with laboratory practices, bacteria culture, and aseptic technique.
• Experience working with GMP-compliant processes and laboratory-based quality testing.
• Comfort working with standard operating procedures (SOPs), work orders, QC inspections, sensory standards, and batch records.
• Interest in supporting new product lines for lotions, creams, personal care, and over-the-counter products as part of a growing operation.
• Eligibility for paid time off benefits, including billable PTO and holidays, in accordance with company policies.

Work Environment

This role is based in a manufacturing…