Quality Assurance Specialist

About Nova Biomedical

Nova Biomedical represents the unified global brand formed from Advanced Instruments and Nova Biomedical, dedicated to advancing innovation and delivering outstanding service across biopharmaceutical and clinical sectors. With headquarters in Massachusetts and nearly 2,000 employees worldwide, the company is recognized as a leader in biotechnology, in vitro diagnostics, and osmolality testing, driven by values of customer focus, creativity, accountability, collaboration, and integrity.

Job Summary

The Quality Assurance Specialist will facilitate the effective operation, regulatory adherence, and ongoing enhancement of the Quality Management System (QMS). This role involves cross-department collaboration to maintain an inspection-ready system, enforce compliance with standards and regulations, assist in external requirement implementations, and spearhead initiatives to improve quality and operational efficiency.

Key Responsibilities

• Maintain and enhance the QMS to ensure compliance with industry regulations, standards, and internal policies.
• Oversee the Documents of External Origin program by monitoring, reviewing, distributing, and assessing the impact of relevant standards and regulatory changes.
• Conduct thorough reviews of quality records to confirm completeness, accuracy, compliance with Good Documentation Practices, and retention policies.
• Provide administrative assistance for calibration and preventive maintenance programs pertaining to equipment, including tracking and reporting activities.
• Support both preparation for and execution of external audits and inspections through record coordination and evidence gathering.
• Perform internal quality audits and facilitate the resolution of findings and corrective actions.
• Create, amend, and review controlled documentation such as SOPs, work instructions, forms, and templates.
• Prepare and examine Engineering Change Orders, Manufacturing Variances, and other modifications under control.
• Contribute to quality systems’ processes including CAPA, nonconformance management, investigations, and shipment holds.
• Monitor project deliverables and ensure timely completion of quality-related tasks by tracking deadlines and actions.
• Identify gaps in documentation, procedural discrepancies, and compliance risks, escalating as appropriate.
• Assist in employee training related to QMS adherence and regulatory compliance.
• Collaborate closely with teams from Manufacturing, Engineering, Regulatory Affairs, Quality Control, Supplier Quality, Supply Chain, Technical Support, and Research & Development.
• Perform additional duties tied to quality systems and compliance as required.

Qualifications and Experience

• A bachelor’s degree in a scientific, technical, business, or related field is preferred.
• Between 3 and 5 years of experience in Quality Assurance, regulatory compliance, document control, or a comparable role in regulated industries.
• Hands-on experience in supporting Quality Management Systems, conducting audits, managing change control, and maintaining compliance is advantageous.
• Background in medical devices, in vitro diagnostics, pharmaceuticals, biotechnology, or similar regulated sectors is highly desired.
• Equivalent education and experience combinations will be considered.

Working Conditions and Physical Requirements

• Comfortable reviewing documentation both digitally and on paper.
• Compliance with personal protective equipment (PPE) usage.
• Frequent access to manufacturing, warehouse, laboratory, and office environments.
• Willingness and ability to travel between local U.S. sites as needed.
• Capacity to sit, stand, walk, and operate a computer for extended durations.
• Capability to lift and carry weights up to 25 pounds.

Why Join Nova Biomedical?

• Comprehensive medical, dental, and vision insurance options.
• Competitive 401(k) company matching program.
• Bonus opportunities, generous paid time off, and holidays.
• Educational tuition reimbursement benefits.
• Flexible and hybrid work arrangements.
• Professional development programs and engaging company events.
• Access to company marketplaces for meals and snacks at various office locations.
• Subsidized cafeteria services at select offices.

Compensation

The expected salary range for this position is from $77,000 to $86,000 annually, reflecting base pay. Actual compensation will be aligned with the candidate’s experience and qualifications and may vary due to factors such as location and education.

Diversity and Inclusion

Nova Biomedical is committed to creating a diverse and inclusive workforce by ensuring all personnel decisions are made without regard to race, religion, color, national origin, citizenship, gender, sexual orientation, veteran status, age, disability, genetic information, or any protected category.