Remote Quality Complaint Investigator

Ultimate; Irvine (CA); Teletrabalho; USD 85 000 - 120 000; Tempo integral

Resumo da oferta

Ultimate is seeking a Product Quality Complaint Investigator to support the complaint program remotely across the United States. The role involves coordinating investigations with contract manufacturers and internal teams, reviewing batch records, and ensuring adherence to GMPs and regulatory expectations.

Strong collaboration, attention to detail, and ability to manage multiple investigations are essential.

Qualificações

• Bachelor's degree in any field.
• Experience in aseptic manufacturing (preferred).
• Experience independently investigating pharmaceutical product complaints and preparing clear, technically defensible reports (preferred).
• Experience with contract manufacturers to obtain information and resolve gaps (preferred).
• Experience with sterile ophthalmic products, filling operations, or packaging defects (preferred).
• Strong attention to detail.
• Knowledge of Microsoft Office Systems.
• Ability to manage multiple investigations against established deadlines with limited supervision.

Responsabilidades

• Support the Product Quality Complaint program from intake to closure.
• Review product complaints as they are initiated.
• Investigate and draft product complaint reports, reviewing batch records and deviations.
• Coordinate with contract manufacturers and internal stakeholders for information and sample evaluations.
• Identify root causes and propose corrective actions for quality review.
• Work with Quality to address review comments and close investigations.
• Ensure compliance with GMPs and government regulations.
• Escalate delays or significant findings and monitor timelines.
• Review trends to identify potential systemic issues.
• Collaborate with Quality, Technical Operations, Supply Chain, and Pharmacovigilance as needed.

Conhecimentos

Aseptic manufacturing

Investigation reporting

Contract manufacturer coordination

Sterile ophthalmic products

Attention to detail

MS Office proficiency

Deadline management

Formação académica

Bachelor's degree

Ferramentas

Microsoft Office

Descrição da oferta de emprego

Ultimate is seeking a Product Quality Complaint Investigator to support the complaint program remotely across the United States. The role involves coordinating investigations with contract manufacturers and internal teams, reviewing batch records, and ensuring adherence to GMPs and regulatory expectations.

Strong collaboration, attention to detail, and ability to manage multiple investigations are essential.