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Quality Associate II

2 months ago

Irving, United States Revision LLC Full time
Job DescriptionJob Description

Scope of Position

Reporting to the Senior Quality Manager, the Quality Associate II is responsible for ensuring that Revision Skincare’s products meet the established standards set by the company. Duties include maintaining strong overall quality control of products made by the company adhering to reliability, performance, and customer expectation. Inspection of products is part of the job with the obligation to report and document findings. This role offers the opportunity to contribute to the continuous improvement of product quality and compliance, while working in a dynamic and collaborative environment.

Job Description/Key Responsibilities

  • Product, Packaging, and Marketing Inspection: Perform routine inspections of products, packaging, and marketing materials to ensure compliance with quality standards and regulatory requirements. Manages product Inventory status in business management software (SAP)
  • Complaint Returns: Manage the process for receiving, evaluating, and addressing customer complaint returns, ensuring timely resolution and proper documentation within the QMS.
  • Analyze complaint data and identify trends: Notify internal and external customers as required.
  • Build data bank from historical responses for customer complaints
  • Internal Audits: Assist in planning, conducting, and documenting internal audits to ensure adherence to GMP, company standards, and regulatory requirements.
  • GMP Compliance: Ensure compliance with Good Manufacturing Practices (GMP) throughout the packaging process by monitoring practices and conducting spot checks.
  • Liaison with Stakeholders: Act as a key point of contact between quality, warehouse, customer service, marketing, and external vendors to resolve quality issues and implement improvements.
  • Warehouse support: on outgoing orders and review/generate documentation.
  • Rework and returns: Assist as required
  • Quality Management System: Work within the company’s QMS to manage quality-related documents, records, and procedures, ensuring accuracy and compliance with company standards.
  • NCR and CAPA: Issue Non-Conformance Reports (NCRs) and assist in the investigation, root cause analysis, and corrective action planning for CAPAs.
  • SOP and WI Generation: Assist in creating and updating Standard Operating Procedures (SOP) and Work Instructions (WI) to ensure they reflect current processes and quality standards.
  • Document Review: Conduct regular reviews of quality-related documents to ensure accuracy, completeness, and compliance with regulatory and company standards.
  • Support Other Quality Functions: Provide assistance to other quality team members as needed, participating in cross-functional quality initiatives and projects.

The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned.

Qualifications and Skills:

  • Bachelor’s degree in a related field (e.g., Quality Assurance, Life Sciences, Engineering) or equivalent work experience.
  • 2+ years of experience in quality assurance or a similar role, preferably within the distribution, packaging, or life sciences sectors.
  • Familiarity with GMP, QMS, and regulatory requirements.
  • Strong verbal and written communication and excellent organizational skills.
  • Detail oriented with problem solving ability
  • Experience with NCR/CAPA processes and internal audits.
  • Proficiency in generating and reviewing SOPs and WIs.
  • Excellent communication and collaboration skills, with the ability to liaise effectively with internal and external stakeholders.
  • Ability to work independently and manage multiple tasks effectively.
  • Proficient in Word and excel

Preferred Qualifications:

  • Knowledge of quality improvement methodologies.
  • Experience with complaint handling systems and tools.