QA Associate - Contract
Quality Specialist - Contract until July 31st
Primarily responsible for assuring compliance with regulatory requirements (FDA, MDD) and ISO standards. Will provide GMP, GLP and ISO 13485 compliance support as necessary.
- Audit reports and raw data for compliance with protocols, SOPs and regulations, including design verification, stability, aging, sterilization, and validation.
- Review manufacturing, QC, release records, and documentation for medical device and drug substance/drug product.
- Oversee change control program, including review of change documentation, tracking activities, and verification of effective implementation.
- 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.
- Identify compliance weaknesses and ensure the implementation of workable solutions.
- Write/revise/review SOPs/INSs, prepare flow charts and other quality documentation, including investigation reports, audit reports, quality metric trend reports, etc.
- 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.
- Experience in GMP or GLP operations.
- Strong understanding of the FDA GMP regulations, Medical Device Directive, ICH Q7, ISO 13485.
- Ability to exercise independent judgment.
- Strong data review and technical writing skills.
- Direct experience with auditing techniques and evidence development.
- 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).
Sthree US is acting as an Employment Business in relation to this vacancy.