Remote Quality Complaint Specialist

We are hiring for a part-time Remote Quality Complaint Specialist. You will have an opportunity to join a leading biopharmaceutical company!

*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 escalate 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.