Quality Assurance Associate
Primarily responsible for assuring compliance with regulatory requirements (FDA, MDD) and ISO standards.Will provide GMP, GLP, and ISO 13485 compliance support as necessary.
- Register Technical Product Complaints (TPCs), monitor timely investigations, prepare customer letters, and ensure timely closure
- Perform trending and data analysis for meetings / reports
- Provide support for Regulatory authority and customer requests regarding complaints
- Audit study reports and raw data for compliance with protocols, SOPs and regulations.
- Review manufacturing, QC, release records, and documentation.
- Write/revise/review SOPs/INSs as necessary
- Provide risk assessment expertise for internal projects and processes.
- Review and provide guidance for various non-conformance situations and investigations activities, evaluate root cause and corrective actions, and ensure documentation is complete, accurate, and closed in a timely manner.
- Perform internal and supplier quality audits and facilitate corrective actions
- Identify compliance weaknesses and ensure the implementation of workable solutions.
- Perform other related duties as required..
- Bachelor’s degree or equivalent in a scientific discipline with a minimum of 5 years’ experience in a pharmaceutical or medical device industry or Master’s Degree with a minimum of 3 years’ experience.
- Minimum 3 years’ experience in regulated operations.
- Strong understanding of the FDA GMP regulations and ISO 13485; GLP/GCP experience is a plus.
- Ability to exercise independent judgment.
- Strong data review and technical writing skills.
- Direct experience with product complaint handling, including investigation and documentation
- High-level understanding of scientific approach and analytical thinking of others.
- Strong communication skills (encompasses verbal, written, interpersonal, listening).
- Ability to influence others.
- High level of attention to detail and accuracy; very observant in order to audit properly.
- Flexible; ability to adapt to changing priorities.
Excellent time management skills (schedules, timelines, task prioritization).