What are the responsibilities and job description for the QAIT Quality Specialist position at Master Compliance?
Job Responsibilities:
Responsibilities include, but are not limited to, the following:
- Engage with both Corporate IT and IOPS IT to ensure IT processes and procedures meet Regeneron’s Quality System requirements.
- Participate in and support Quality Risk Management (QRM) principles during formal and informal risk assessment initiatives.
- Provide support and guidance for quality system record activities such as change controls, corrective and preventive action plans (CAPAs), risk assessments, data integrity initiatives, deviations, internal and external audits, standard operating procedures (SOPs), work instructions/job aids, policies, etc.
- Offer ongoing support to the Quality Auditing function concerning IT vendors and audits.
- Assist in the development, review, and approval of Quality Assurance Agreements (QAAs), along with the Approved Supplier List (ASL) process.
- Collaborate with other functional areas to collect information and provide guidance throughout all stages of the quality management system and improvement projects.
- Ensure new systems, processes, and procedures comply with SOPs, WIs, data integrity, and regulatory guidelines for IT and software validation.
- Assist in resolving inspection management concerns related to software applications, processes, procedures, and data integrity.
Experience:
- 7 years of experience in IT, Computer Science, Engineering, or Chemistry in an FDA-regulated manufacturing environment.
- In-depth understanding of IT CSV and QAIT roles and responsibilities in supporting GxP compliance.
- Experience in an FDA-regulated environment with a strong emphasis on a risk-based approach to validation/qualification.
- Strong knowledge of FDA CFRs, Eudralex, and other biotech/pharma industry regulations, especially related to IT, laboratory systems, automation, and manufacturing.
- Strong knowledge of Data Integrity, System Development Life Cycle (SDLC) validation methodology, and Software Quality requirements.
- Understanding of root cause analysis and risk management techniques.
- Experience with quality management systems, including change control, incident management, and deviation management.
- Strong project management experience, leading efforts requiring coordination between cross-functional teams in at least one area of systems validation (e.g., laboratory equipment, facilities, utilities, manufacturing equipment, information systems, etc.).
- Continuous drive for process improvement to enhance performance.
- Excellent technical writing and communication skills.
- Strong analytical and problem-solving abilities.
