Quality Assurance Specialist

2 weeks ago

Hayward, California, United States Planet Pharma Full time

Key Responsibilities:

  • Support the management of nonconforming materials (NC), return merchandise authorizations (RMA), and deviations to ensure prompt and effective resolution of manufacturing disruptions and component quality challenges.
  • Develop expertise in SAP workflows related to RMA and NCM management.
  • Execute decisions regarding RMA in accordance with Quality Management System (QMS) standards.
  • Ensure the accuracy and compliance of NC and deviation documentation.
  • Plan and manage all aspects of material containment, including both physical and system transactions, as well as the oversight of holds.
  • Collaborate with cross-functional teams to implement process enhancements and address material or procedural issues.
  • Support global project rollouts, including system testing and communication with local stakeholders.
  • Verify the adequacy of nonconformance, deviation, and corrective action (CAPA) records, investigations, and resolutions.
  • Familiarize yourself with relevant technologies to engage in technical discussions and risk-based decision-making.
  • Assist with material inspections as required.
  • Maintain documentation pertinent to assigned responsibilities, such as work instructions and forms.
  • Encourage a "Zero Defect" philosophy throughout the manufacturing process.
  • Provide logistical support during external audits.
  • Perform additional tasks as assigned.

The responsibilities listed above are essential but not exhaustive, and may evolve based on business requirements.

Qualifications:

  • 0-3+ years of experience in Quality Assurance within a regulated manufacturing environment (equivalent manufacturing experience demonstrating a Quality mindset may be considered).
  • Experience in applying quality regulations and standards (e.g., 21CFR 820, ISO) to real-world scenarios.
  • Practical knowledge of design controls, risk management, validation, and/or change control is preferred.
  • Familiarity with CAPA and failure investigation methodologies is advantageous.
  • Ability to adapt to a fast-paced, dynamic work environment with changing priorities.
  • Strong verbal and written communication skills, with the ability to collaborate effectively with diverse teams and work independently.

Education:

A Bachelor's degree, preferably in an engineering discipline.

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