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.
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.
This position may also include the following conditions:
Standing
Walking
Bending
The items described here are representative of those that must be met successfully to perform the essential functions of this job.
Sponsorship or support for work authorization, including visas, is not available for this position.
Benefits
Health insuranceDental insuranceVision insurance401(k)Performance bonus
Additional Information
A career at Resilience is more than just a job - it's an opportunity to change the future.
Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made . We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.
For more information, please visit www.resilience.com
Position Description
The Senior Specialist, Product Complaints is responsible to ensure timely evaluation, investigation, and closure of product quality complaints in compliance with GMP, regulatory, and company requirements.
Position Responsibilities
Product Complaints
Complaint Intake & Triage: Manage the process of receiving, logging, and categorizing incoming product complaints.
Investigation & Analysis: Oversee the investigation of complaints, ensuring thoroughness and accuracy, and analyzing data to identify trends and potential product issues.
Compliance: Ensure all complaint handling activities comply with relevant regulations, company procedures.
Communication & Reporting: Communicate investigation findings, both internally and externally, and prepare reports on complaint trends and performance.
Process Improvement: Identify opportunities to improve complaint handling processes and collaborates with other departments to implement solutions.
Cross-functional Collaboration: 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.
Training & Mentorship: Provide guidance and training to team members on complaint handling procedures and best practices.
Documentation: 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).
Performance Monitoring: Track metrics related to complaint handling and take corrective actions as needed.
Inspection Readiness:
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.
Work Schedule
Monday - Friday
Resilience · - OH - West Chester