Quality Assurance Specialist

• Pay or shift range: $30.77 USD to $40.38 USD. The estimated range is the budgeted amount for this position. Final offers are based on various factors, including skill set, experience, location, qualifications and other job-related reasons.

Essential Duties and Responsibilities:

• Review documentation of incoming materials for accuracy and compliance to specifications and procedures for product release and disposition as appropriate.
• Inspect, document and release finished goods and/or Promotional Literature/Collaterals for compliance with established quality specifications. Prepare set amount of finished goods for retention samples.
• Work with contract manufacturing, suppliers, receiving, operations and materials personnel to accurately complete required QC evaluation and documentation, and determine correct disposition.
• Track, update and maintain established quality matrices, e.g., the receiving incoming material log.
• Detect nonconforming conditions during inspection and accurately document each condition. Support correct disposition per established specifications, escalating exceptions to management. Assist with manufacturing (internal and contract), to develop and recommend actions addressing nonconforming conditions and processes.
• Understand principles of MIL-STD-105E Single and Double AQL Sampling Plan; perform as needed.
• Maintain Packaging Component Specification Inventory Log. Assist in maintenance and population of primary and secondary packaging component materials, suppliers, weights for legacy and recent launch items.
• Assistance on coordinating package qualification tests/result log with test labs and sample logistics.
• Monitor and trend QC and incoming receiving data. Act on trends by alerting management to out of specification (OOS) conditions or negative trends. Prepare and report data and trends as required.
• Coordinate quality investigations with contract manufacturers and other third parties. Collect, organize, and technically summarize data in support of investigation plans.
• Identify and recommend process improvements within own area of work for management review.
• Maintain current knowledge of the basic requirements for compliance in own area of work and comply with those requirements.
• Support internal and external customers by responding to quality inquiries or requests in a timely manner.
• Identify opportunities to continuously improve quality, cost, and inspection turnaround time to achieve the overall value chain.
• Receive and log product complaints, manage complaint samples per established procedures, support complaint investigations by gathering data from contract manufacturers or suppliers, and close complaint records with appropriate documentation as directed by management.
• Support document control activities including drafting SOP revisions, routing documents for review and approval, tracking biennial review schedules, and maintaining document change records in the change control log.
• Support the maintenance and updating of ZO Skin Health specifications, including bulk, finished goods, stability, and Production Fill & Assembly (PF&A), by coordinating documentation, tracking revisions, and updating records in accordance with established procedures and management direction.
• Fulfill international distributor requests for finished good Certificates of Analysis by retrieving documentation from contract manufacturers, uploading to the designated repository, and maintaining a request tracking log.
• Support the Brand Protection team by reviewing product images and lot information against production records to verify product authenticity, and respond with findings per established templates.
• Other quality activities, as directed by management.

Knowledge, Skills & Abilities:

• Excellent verbal and written communication skills in English, with strong analytical and mathematical abilities.
• Bachelor’s degree in a scientific discipline, such as Biology, Chemistry, or a related field, required.
• 2–3 years of experience in quality assurance, quality control, laboratory testing, research and development, or a related field, preferably within a cGMP-regulated pharmaceutical, OTC, or cosmetic environment.
• 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.
• Proficiency in Microsoft Office applications, including Word,…