Remote Quality Complaint Specialist

Ultimate; Irvine (CA); Remote; USD 85,000 - 120,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Aseptic manufacturing

Investigation reporting

Contract manufacturer coordination

Sterile ophthalmic products

Attention to detail

MS Office proficiency

Deadline management

Education

Bachelor's degree

Tools

Microsoft Office

Job description

Job Description

*NOTE*: This position is fully remote with the flexibility to work your own schedule and work in any location within the US.

Overview

This position is responsible for supporting the Product Quality Complaint program from an operations perspective and ensuring that all complaints are handled in accordance with GMPs and health authority requirements and expectations.

This individual will independently execute and coordinate technical complaint investigations with contract manufacturers and internal stakeholders. Quality retains final complaint approval and closure; complaint classification and regulatory reportability decisions remain with the designated Quality and Regulatory functions.

Responsibilities

• Support of the product complaint program from intake to closure.
• Review Product Complaints as they are initiated.
• Conduct and draft Product Complaint investigations related to drug product manufacturing and packaging, including review of batch records, deviations, manufacturing history, packaging records, and complaint sample evaluations.
• Coordinate with contract manufacturers and internal stakeholders to obtain investigation information, arrange sample evaluations, and resolve technical questions.
• Assess potential root causes, document technically justified conclusions, and recommend corrective and preventive actions for Quality review.
• Work with Quality to address review comments and support timely investigation approval and complaint closure.
• Understand the regulatory environment and work proactively to evolve systems and procedures to ensure the product complaints are managed in accordance with company policies and government regulations.
• Ensure monitoring and appropriate escalation of Product Complaints, including expedited complaints.
• Track assigned investigations and outstanding actions against established deadlines; proactively follow up and elevate delays or significant findings.
• Review recurring complaints and trends by defect type, batch, and manufacturing site to identify potential systemic issues.
• Coordinate with Quality, Technical Operations, Supply Chain, and Pharmacovigilance, as appropriate, when complaints indicate potential product quality or patient safety concerns.

Qualifications

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

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, Los Angeles County Fair Chance Ordinance, and San Francisco Fair Chance Ordinance.

Job Reference: JN -102026-432889