Quality Assurance Specialist

ZO Skin Health • Irvine, CA

20d • Hybrid

About The Position

The Quality Assurance Specialist supports quality assurance and control activities for products, materials, packaging components, and documentation. The role reviews incoming-material documentation and inspects and releases finished goods and promotional materials against established requirements. It also supports quality investigations, complaint handling, document control, product specifications, Certificates of Analysis requests, and brand-protection reviews. The position collaborates with contract manufacturers, suppliers, internal teams, laboratories, and other third parties to evaluate quality issues, determine dispositions, maintain records, and identify process improvements.

The position is based in Orange County and is hybrid, with two remote workdays. The work schedule is five days per week, eight hours per day. Start times may vary, with hours typically from 8 a.m. to 5 p.m.; schedules and shifts may change based on business conditions and needs. The role has no supervisory responsibilities. The work takes place indoors in a professional office environment, with carpeted office and conference-room floors and typical vinyl flooring in hallways, break rooms, and computer rooms. It is sedentary, involving constant sitting and constant use of the upper extremities to reach, handle, and position tools and equipment. Occasional exertion of up to 10 pounds, or frequent negligible force, may be required. The employee must follow safety protocols and maintain a professional appearance.

Requirements

• Bachelor’s degree in a scientific discipline, such as Biology, Chemistry, or a related field.
• 2–3 years of experience in quality assurance, quality control, laboratory testing, research and development, or a related field.
• Strong knowledge of current Good Manufacturing Practices (cGMP) applicable to pharmaceutical, OTC, and cosmetic products.
• Working knowledge of global cosmetic and drug regulations, including the Food, Drug, and Cosmetic Act, 21 CFR Parts 210 and 211, and 21 CFR Part 11.
• Excellent verbal and written communication skills in English.
• Strong analytical and mathematical abilities.
• Proficiency in Microsoft Office applications, including Word, Excel, and PowerPoint.
• Ability to prepare comprehensive, accurate, and detailed reports.
• Ability to collaborate effectively across multiple departments.
• Strong organizational and time-management skills, including the ability to manage multiple projects, prioritize competing demands, and meet tight deadlines.
• Strong critical-thinking, analytical, and problem-solving skills, with a proactive approach to identifying and resolving issues.
• Ability to follow proper safety protocols and maintain a professional and polished appearance.

Nice To Haves

• Experience in a cGMP-regulated pharmaceutical, OTC, or cosmetic environment.

Responsibilities

• Review incoming-material documentation for accuracy and compliance with specifications and procedures, and support product release or disposition.
• Inspect, document, and release finished goods and promotional literature or collateral for compliance with established quality specifications.
• Prepare set amounts of finished goods for retention samples.
• Coordinate with contract manufacturing, suppliers, receiving, operations, and materials personnel to complete QC evaluations and documentation and determine appropriate disposition.
• Track, update, and maintain quality matrices, including the incoming-material receiving log.
• Detect and document nonconforming conditions, support disposition according to specifications, and escalate exceptions to management.
• Assist internal and contract manufacturing teams in developing and recommending actions for nonconforming conditions and processes.
• Apply MIL-STD-105E Single and Double AQL Sampling Plan principles as needed.
• Maintain the Packaging Component Specification Inventory Log and assist with packaging-component records, supplier information, weights, and legacy and recently launched items.
• Coordinate packaging qualification tests, results logs, laboratory testing, and sample logistics.
• Monitor and trend QC and incoming-receiving data; alert management to out-of-specification conditions or negative trends and prepare data and trend reports as required.
• Coordinate quality investigations with contract manufacturers and other third parties; collect, organize, and technically summarize supporting data.
• Identify and recommend process improvements within the assigned work area for management review.
• Maintain current knowledge of applicable compliance requirements and follow them.
• Respond to internal and external customer quality inquiries and requests in a timely manner.
• Identify opportunities to improve quality, cost, and inspection turnaround time.
• Receive and log product complaints, manage complaint samples, support investigations by gathering supplier or manufacturer data, and close complaint records with appropriate documentation as directed.
• Support document control, including drafting SOP revisions, routing documents for review and approval, tracking biennial reviews, and maintaining change-control records.
• Support maintenance and updating of ZO Skin Health bulk, finished-goods, stability, and PF&A specifications by coordinating documentation, tracking revisions, and updating records.
• Fulfill international distributor requests for finished-goods Certificates of Analysis by retrieving documents from contract manufacturers, uploading them to the designated repository, and maintaining a tracking log.
• Support Brand Protection by comparing product images and lot information with production records to verify authenticity and reporting findings using established templates.
• Perform other quality activities as directed by management.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level