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Quality Assurance Associate

3 months ago

Valencia, United States CC Wellness LLC Full time
Job DescriptionJob Description

Do you have experience in Quality Systems? Do you have Experience with FDA, ISO audits? Have you made CAPA reports? Apply to join our team 

Position Summary:

The Quality Systems (QS) Associate is responsible for supporting all daily QS activities.  This person will support the Quality Systems department and cross-functional personnel in all quality documentation requirements, in accordance with Good Documentation Practice (GDP) and relevant compliance requirements.  This person will also support audit activities, incident investigations and reports, and procedure writing to support the Quality Management System.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform the following satisfactorily; other duties may be assigned. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Support the development, maintenance, and continuous improvement of quality programs, processes, and procedures as needed.
  • Create/review SOPs, work instructions, and forms regarding the Quality Management System.
  • Support completion of Nonconformance Reports (NCRs), deviation reports, Corrective Action and Preventive Action (CAPA) reports, and change controls, including updating the respective logs.
  • Support the Feedback/Complaint Handling procedures, including communicating the need for any investigations and completion of customer complaint reports.
  • Support vendor/supplier evaluation records, audits, and ongoing monitoring of vendor performance.
  • Support internal audit program, including execution and all corresponding documentation.
  • Support document control needs for CC Wellness policies and procedures, including documentation reviews and record retention.
  • Perform periodic documentation reviews and scanning of Production records.

Skills and Qualifications:

Education/Experience:

  • Associate’s degree in a technical, scientific, or related discipline, and at least one-year related experience and or training, or an equivalent combination of education and experience.

Computer Skills:

  • Microsoft Office (Word, Excel, PowerPoint, Outlook)
  • ERP or QMS experience preferred

Physical Demands:  The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The individual will be expected to work for extended periods sitting at a desk, performing work on a computer and/or reviewing paper documents.

CC Wellness is an equal opportunity employer of protected veterans and individuals with disabilities. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of disability or their protected veteran status.

Company DescriptionCC Wellness is a rapidly growing California-based pharmaceutical company focused on delivering personal care and intimate wellness products in a socially responsible manner through science-based innovation and world-class manufacturing. Even the smallest choices in life can lead to big changes. Like a ripple resonating from a single raindrop, the impact you make today can transform someone’s wellbeing tomorrow. Come join us and make waves togetherCompany DescriptionCC Wellness is a rapidly growing California-based pharmaceutical company focused on delivering personal care and intimate wellness products in a socially responsible manner through science-based innovation and world-class manufacturing. Even the smallest choices in life can lead to big changes. Like a ripple resonating from a single raindrop, the impact you make today can transform someone’s wellbeing tomorrow. Come join us and make waves together