QA Systems SpecialistThe QA Systems Specialist will be operating in full compliance with applicable hygiene, safety, quality, and regulatory standards, and in alignment with the organization's framework, company's procedures, and the defined scope of responsibility the role is accountable for. The QA Systems Specialist is responsible for supporting daily Quality Assurance activities to ensure compliance with cGMP requirements, regulatory standards, and company quality systems. This role supports the maintenance and execution of quality systems and ensures the Raleigh site remains inspection ready at all times. The QA Systems Specialist collaborates with cross-functional teams, including Manufacturing, Quality Control, Supply Chain, Engineering, and Regulatory Affairs, to maintain product quality, compliance, and operational excellence. Operating in accordance with all safety, quality, and regulatory requirements, this position helps drive continuous
YOUR ROLE- Promote and foster a culture of quality throughout the site by ensuring adherence to quality principles, regulatory requirements, and company standards.
- Partner with cross-functional teams and site leadership to support Quality Systems activities and drive compliance-focused decision-making.
- Collaborate with Global Regulatory Affairs to ensure site compliance with global product registrations.
- Ensure compliance with applicable FDA, cGMP, international regulatory requirements, and company quality systems.
- Review and assess quality-related documentation, including Change Controls, risk assessments, deviations, investigations, and records supporting changes to utilities, manufacturing, and Quality Control operations.
- Support management of the Change Control system through review and approval of change controls, KPI tracking, and system administration.
- Support Management Review meetings through data collection, analysis, and presentation of quality system metrics to site leadership.
- Compile and analyze Quality Systems data for Annual Product Reviews and other site quality reporting requirements.
- Provide Quality Assurance oversight and guidance for change controls and quality system activities.
- Identify, assess, escalate, and communicate quality risks, compliance concerns, and regulatory issues to site leadership in a timely manner.
- Support customer audits, regulatory inspections, and audit readiness activities by providing documentation, responses, and Quality Assurance expertise.
YOUR BACKGROUNDRequired Qualifications- Bachelor's degree in Chemistry, Biology, Microbiology, Pharmaceutical Sciences, Engineering, or another scientific discipline.
- Minimum of 5 years of experience in the pharmaceutical, biotechnology, or other cGMP-regulated industry.
- Experience supporting Quality Systems, Quality Operations, Validation, Manufacturing Quality, or related quality functions.
- Experience participating in regulatory inspections, customer audits, and internal audit programs.
- Experience with Change Control processes as an initiator, reviewer, or Quality approver.
- Demonstrated knowledge of Quality Assurance principles, quality systems, and regulatory compliance within a regulated environment.
- Strong written, verbal, and interpersonal communication skills with the ability to collaborate effectively across functional areas.
- Strong organizational, analytical, problem-solving, and decision-making skills.
- Proficiency in Microsoft Office applications, including Word, Excel, Outlook, and PowerPoint.
Preferred Qualifications- Working knowledge of cGMP requirements and FDA and international regulatory expectations.
- Experience with electronic Quality Management Systems (eQMS), including management of deviations, CAPAs, change controls, document control, and training records.
- Experience supporting capital projects, facility expansions, equipment qualification, validation, or process implementation activities within a regulated environment.
- Experience administering or managing Change Control systems.
- Knowledge of risk management principles, quality improvement methodologies, and quality risk assessment tools.
- Familiarity with data integrity requirements and electronic record regulations, including 21 CFR Part 11.
- Experience supporting Annual Product Reviews (APRs), Management Review processes, or site quality metrics reporting.
- ASQ, RAPS, or other relevant quality-related certifications preferred.
