Sr. Quality Assurance Specialist

Company: ZO Skin Health, Inc.
Location: Irvine
Posted on: April 8, 2021

Job Description:

Position: Sr. Quality Assurance Specialist Reports to: Director of Quality Job Description

• Help develop, implement, maintain and continually assess quality assurance function applicable to regulated activities and company standards.
• Perform a wide variety of activities to ensure compliance with applicable quality and regulatory requirements.
• Participate in developing, reviewing, and maintaining documents to include corporate level Standard Operating Procedures (SOPs) to ensure quality objectives are met.
• Support all activity for new and existing products, including incorporating documentation from other departments into the Document Control System.
• Inspect finished goods for compliance with established quality specifications.
• Liaise with contract manufacturers, receiving, operations and materials personnel to complete require QC testing, disposition and documentation.
• Review batch records and disposition as required from contract manufactures.
• Assist in relevant training to the Quality team.
• Assist in Product Development as it relates to Quality Assurance activity as well as Technology Transfers.
• Detect nonconforming conditions during inspection and accurately document each condition.
• Establish and maintain compliant quality systems to include SOP, vendor qualification, change control, document control, CAPA, deviations and investigation, complaint handling and internal audits.
• Monitor and trend quality related issues and complaint data. Act on trends by alerting management to out of specification (OOS) conditions or negative trends. Prepare reports and report data and trends as required.
• Perform investigations and testing related to nonconforming product or customer complaints as required.
• Coordinate quality investigations with suppliers, vendors, contract manufacturers and other third parties. Collect, organize and summarize data in support of investigation plans as needed.
• Route for approval SOPs, forms, Change Control. Ensure all documents in Quality Management Systems are issued, reviewed, documented and approved.
• Develop and implement process improvements within own area and work effectively with teams to identify and develop process improvements. Participate in other continuous improvement activities.
• Maintain current knowledge of basic requirements for compliance. Interface with Regulatory to ensure good regulatory and clinical practices are met.
• Support internal and external customers by responding to quality inquiries and serve as the quality representative on the complaint review committee.
• Other quality activities, as directed by management. Requirements Minimum EducationBachelor's degree in a scientific discipline. Years of experience3-7 years of related work experience in quality assurance/quality control working in a cGMP setting as applicable to the pharmaceutical, OTC and cosmetic environment. Skills and Knowledge
  • Strong knowledge of current Good Manufacturing Practices for pharmaceuticals, OTC, and cosmetics
  • Working knowledge of global cosmetic and drug regulations including Food, Drug and Cosmetic Act, 21 CFR 210 and 211 Good Manufacturing Practices, and 21 CFR 11.
  • Strong interpersonal, communication and organizational skills.
  • Proficiency in Word, Excel, PowerPoint, Outlook
  • Demonstrate sound technical, interpersonal and problem-solving decision-making skills
  • Ability to convey information in a clear, focus and concise manner at all levels with cross functional departments.
  • Self-motivated with a collaborative attitude and a desire to continuously learn

Keywords: ZO Skin Health, Inc., Irvine , Sr. Quality Assurance Specialist, Other , Irvine, California