Assistant

In-Process Quality Assistant

The In-Process Quality Assistant is responsible for supporting manufacturing operations in an ISO 22716 compliant contract manufacturing environment producing cosmetic and industrial products. This role performs in-process inspections and monitoring activities to ensure products are manufactured, filled, and packaged in accordance with approved procedures, specifications, and current Good Manufacturing Practices (cGMP). The position works closely with Production and Quality Assurance to ensure product quality, traceability, and documentation integrity throughout the manufacturing process.

Qualification Requirements

• Experience in contract manufacturing environments
• Familiarity with cosmetics, personal care, or industrial product manufacturing
• Exposure to FDA cosmetic regulations, ISO standards, or internal quality systems
• Prior in-process inspection or floor QA experience

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Minimum Qualification (Must have/non-negotiable)

• High school diploma or equivalent
• 1-3 years of experience in a GMP or ISO-regulated manufacturing environment, preferably cosmetics, personal care, or industrial products
• Basic understanding ISO 22716 and cGMP principles
• Ability to read and interpret batch records, SOPs, and specifications
• Ability to follow controlled documents and accurately complete GMP documentation
• Strong attention to detail and compliance mindset

Knowledge, Skills and Abilities

• Detail-oriented with strong observational skills
• Clear written and verbal communication
• Ability to recognize and escalate quality risks
• Team-oriented with a proactive mindset
• Ability to work effectively on the manufacturing floor

Essential Functions

• Perform in-process quality checks in accordance with ISO 22716 requirements during compounding, filling, labeling, and packaging operations
• Verify that manufacturing activities are executed per approved batch records, work instructions, SOPs, and customer specifications
• Conduct and document line clearance activities prior to start-up, changeovers, and completion of production rungs
• Ensure raw materials, bulk, and finished products are properly identified, segregated, and traceable at all times.
• Identify, document, and immediately report non-conformances, deviations and out-of-specification conditions
• Apply and maintain quality status controls (e.g., hold, release, reject) as directed by Quality Assurance
• Support investigations and corrective actions related to in-process quality issues
• Ensure production areas comply with ISO 22716 requirements for cleanliness, hygiene, and organization
• Communicate quality requirements and concerns to Production and QA personnel in real time
• Support internal audits, customer audits, and regulatory inspections as assigned

Physical Demands

Standing, sitting, stooping, hearing in a noisy environment, able to see color differences, kneeling, reaching, feeling, depth perception, crouching, handling packaging. Must be able to lift up to 25 pounds frequently

Work Environment

Exposure to a Production area, chemical mixing, gowning area, laboratory environment, packaging lines, heat or cold, exposure to chemicals, wet and/or humid conditions, proximity to moving mechanical parts.