Quality Assurance Specialist at ACROBIOSYSTEMS INC – Newark, Delaware

ACROBiosystems is a worldwide leader in developing and manufacturing recombinant proteins and critical reagents/assays to support drug development and clinical applications from target discovery and validation, candidate drug screening and optimization, CMC development, preclinical and clinical studies, commercial production, and companion diagnostics. We are committed to excellence in providing quality products and services and accelerating the process of therapeutic development.

Our mission is to accelerate the process of target therapeutic drug development. We aim to be a cornerstone of life science and healthcare companies. We value the fast growth in a global market over a challenging time by excelling through quality, performance, and innovation, empowering our employees with trust, value, and respect, embracing diversity, and encouraging cross-functional collaboration and continuous learning.

Job Summary

The Quality Assurance Specialist plays a key role in establishing, maintaining, and improving the site’s Quality Management System (QMS) in alignment with ISO 17025 and ISO 9001. This role supports internal and external audits, oversees document control, coordinates NC, CAPA, and risk management activities, and partners with laboratory, production, and leadership teams to ensure ongoing compliance and operational excellence.

Essential Functions

Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions.

• Implement, maintain, and improve QMS processes aligned with ISO 17025 and ISO 9001.
• Manage the preparation, revision, and control of the Quality Manual and procedure documents.
• Maintain daily operation of QMS systems, ensuring compliance with internal and external requirements.
• Develop internal audit plans, assign auditors, and coordinate audit execution.
• Support external audits and proxy auditor activities.
• Ensure audit schedule adherence and timely closure of findings.
• Lead nonconformance control activities.
• Track, verify, and document corrective and preventive actions.
• Support root cause investigations and quality issue resolution.
• Oversee document systems for laboratory and production areas.
• Maintain external standards, regulations, and ISO-related documents.
• Support leadership in establishing quality policies and objectives.
• Prepare required inputs and outputs for management review meetings.
• Coordinate QMS programs such as CAPA, internal audits, supplier qualification, and product lifecycle risk management.
• Review manufacturing and QC documentation, including batch records and QC reports.
• Support new operational activities, including risk assessments, supplier approvals, and method verification/validation.
• Assist in determining and delivering ISO-related quality system training.
• Promote good documentation practices and quality culture across the site.

• Bachelor’s degree in Biology, Chemistry, Biochemistry, or related field and 3+ years of QA experience in biotech, pharma, or medical devices OR Master’s degree in a related field and 2+ years of QA experience
• Experience working within ISO 17025, ISO 9001, or ISO 13485 systems

• Certifications issued by global quality organizations (e.g., ISO 17025 or 9001 auditor, CQE).

• Knowledge and understanding of ISO quality system standards (either ISO 17025, ISO 9001 or ISO 13485) required, as evidenced by a successful track record in external supplier audit or internal quality audit programs and by successfully working within a quality management system
• Working knowledge and demonstrated experience using root cause analysis and process troubleshooting tools.
• Familiarity with document control and good documentation practices, and experience creating, writing, and revising policies, procedures, work instructions, and forms as needed.
• Must demonstrate good professional judgment and reliability.
• Detail-oriented and highly accurate.
• Excellent oral and written communication skills.