Quality Assurance Systems Specialist

2 weeks ago

Santa Clarita, California, United States CC Wellness Full time

Overview: This position is ideal for a recent graduate with relevant experience in a comparable role.

About CC Wellness: CC Wellness is a dynamic pharmaceutical organization based in California, dedicated to providing personal care and intimate wellness products through responsible practices grounded in scientific innovation and superior manufacturing. Every decision we make can lead to significant changes, much like the ripple effect of a single raindrop. The impact you create today can enhance someone's wellbeing tomorrow. We invite you to contribute to this mission.

Position Overview: The Quality Systems Associate plays a crucial role in assisting with daily Quality Systems operations. This individual will collaborate with the Quality Systems department and cross-functional teams to fulfill all quality documentation needs, adhering to Good Documentation Practices (GDP) and relevant compliance standards. Responsibilities will also include supporting audit processes, incident investigations, and the creation of procedures that uphold the Quality Management System.

Key Responsibilities: To excel in this role, the individual must competently perform the following tasks; additional duties may be assigned as necessary. Reasonable accommodations may be provided to enable individuals with disabilities to fulfill essential functions.

  • Assist in the development, upkeep, and ongoing enhancement of quality programs, processes, and procedures as required.
  • Draft and review Standard Operating Procedures (SOPs), work instructions, and forms related to the Quality Management System.
  • Facilitate the completion of Nonconformance Reports (NCRs), deviation reports, Corrective Action and Preventive Action (CAPA) reports, and change controls, including the maintenance of respective logs.
  • Support the Feedback/Complaint Handling procedures, ensuring timely communication regarding investigations and completion of customer complaint documentation.
  • Assist in vendor/supplier evaluation documentation, audits, and continuous monitoring of vendor performance.
  • Contribute to the internal audit program, including execution and all related documentation.
  • Manage document control requirements for CC Wellness policies and procedures, including documentation reviews and record retention.
  • Conduct periodic reviews of documentation and scanning of production records.

Physical Requirements: The physical demands outlined here represent those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

While executing the responsibilities of this role, the employee is frequently required to sit, use hands for manipulation, and communicate verbally. Occasionally, the employee may need to stand, walk, and reach with hands and arms. The employee must regularly lift and/or move up to 10 pounds. Specific vision abilities required for this position include the ability to adjust focus and perceive colors.

The above job description is not intended to be an exhaustive list of duties and standards for the position. Incumbents will adhere to any additional instructions and perform any related tasks as assigned by their supervisor.

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