Resilience · 1 day ago
Senior Specialist, Product Complaints
West Chester, OH
Full-time
Onsite
Mid, Senior Level
$80K/yr - $118K/yrResilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. The Senior Specialist, Product Complaints is responsible for ensuring timely evaluation, investigation, and closure of product quality complaints in compliance with GMP, regulatory, and company requirements.
BiopharmaBiotechnologyHealth CareLife SciencePharmaceutical
No H1B
Responsibilities
Manage the process of receiving, logging, and categorizing incoming product complaints
Oversee the investigation of complaints, ensuring thoroughness and accuracy, and analyzing data to identify trends and potential product issues
Ensure all complaint handling activities comply with relevant regulations, company procedures
Communicate investigation findings, both internally and externally, and prepare reports on complaint trends and performance
Identify opportunities to improve complaint handling processes and collaborates with other departments to implement solutions
Work with various departments (e.g., quality assurance, manufacturing, quality control) to resolve complaints and prevent future occurrences. Coordinate with the Investigations Team to identify the complaint investigation scope
Provide guidance and training to team members on complaint handling procedures and best practices
Ensure all complaint-related documentation is accurate, complete, and maintained according to regulatory requirements. Review and approve complaints investigations, complaint-related documentation (e.g., forms, SOPs, work instructions)
Track metrics related to complaint handling and take corrective actions as needed
Participate in internal audits and external quality system inspections conducted by the FDA and other regulatory agency representatives including client quality audits
Provide active support to the Logistics Center or Inspection Room during an external audit/inspection
Qualification
Required
Strong knowledge of cGMP in the Pharma/Biotech industry to include FDA, EU, JP regulatory requirements as well as ICH/ISO guidelines
Knowledge of pharmaceutical and biotechnology processes: sterile product manufacturing processes, inspection, packaging, labelling, testing, etc
Excellent investigational and QA problem solving skills
Demonstrated ability to work independently and collaboratively on multidisciplinary and multifunctional teams
Strong interpersonal, communication, technical writing, and influencing skills
Preferred
Bachelor's degree in a science/technical field such as pharmacy, biology, chemistry, or engineering
Experience in product complaint management, quality assurance, or a related field
Experience with complaint management systems and databases
ASQ certifications (e.g., CQA, CQE, and CQM)
Active member of pharmaceutical trade associations such as ISPE, PDA, etc
Benefits
Annual cash bonus program
401(k) plan with a generous company match
Great healthcare (including medical, dental and vision)
Family building benefits
Life and disability insurance
Flexible time off
Paid holidays
Other paid leaves of absence
Tuition reimbursement
Support for caregiving needs
Company
Resilience
Resilience is a biomanufacturing company that provides access to complex medicines and protects biopharmaceutical supply chains.
Founded in 2020
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
$3.36BKey Investors
Oak Hill AdvisorsAdministration for Strategic Preparedness and ResponseU.S. Department of Defense,U.S. International Development Finance Corp
2025-10-29Debt Financing· $825M
2024-10-03Grant· $17.5M
2023-03-24Debt Financing· $410M
Leadership Team
William Marth
President & Chief Executive Officer
Susan Billings
Chief Commercial Officer (CCO)
Recent News
Help Net Security
2025-11-11
2025-11-05
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