QA Systems Specialist

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.

Required 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.