Sr. Quality Assurance Specialist
Company: ZO Skin Health, Inc.
Posted on: April 8, 2021
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
- 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
- Liaise with contract manufacturers, receiving, operations and
materials personnel to complete require QC testing, disposition and
- Review batch records and disposition as required from contract
- 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
- 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
- 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
- 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
- Proficiency in Word, Excel, PowerPoint, Outlook
- Demonstrate sound technical, interpersonal and problem-solving
- 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
Keywords: ZO Skin Health, Inc., Irvine , Sr. Quality Assurance Specialist, Other , Irvine, California
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