QA Associate I, Sterilization Assurance

Position Summary

B. Braun Medical Inc. is seeking a QA Associate, Sterilization Assurance to support quality oversight of sterilization and product release activities within a GMP-regulated manufacturing environment. This role is responsible for reviewing sterilization records, batch documentation, and quality system records to ensure compliance with regulatory requirements, Good Documentation Practices (GDP), and data integrity standards. The QA Associate partners closely with Manufacturing, Engineering, Facilities, and Quality teams to support product disposition, release activities, and resolution of quality events.

In This Role, You Will Have the Chance To:

• Review sterilization records, batch documentation, and quality records for accuracy, completeness, and compliance with GMP, GDP, and data integrity requirements.

• Utilize electronic systems including LIMS, MES, Wonderware, and Electronic Batch Records (EBR) to support sterilization review and release activities.

• Identify, document, and escalate deviations, nonconformances, and documentation discrepancies in accordance with established procedures.

• Verify sterilization documentation and traceability records to support product release decisions.

• Collaborate with Manufacturing, Quality, Engineering, and Facilities teams to resolve quality and documentation issues.

• Support product disposition and release activities while maintaining audit-ready records.

• Participate in continuous improvement initiatives to enhance compliance and operational efficiency.

Essential Requirements

• High School Diploma or GED required.

• Minimum one (1) year of experience in manufacturing, quality, laboratory, or FDA-regulated environments.

• Experience reviewing documentation for accuracy, completeness, and compliance.

• Working knowledge of GMPs, GDP, and quality system requirements.

• Strong attention to detail and commitment to data integrity.

• Proficiency with Microsoft Office and electronic quality systems.

• Strong organizational, analytical, and problem-solving skills.

• Ability to work non-standard hours as business needs require.

• Regular and predictable onsite attendance required.

Preferred Qualifications

• Associate or Bachelor's degree in Biology, Microbiology, Chemistry, Biomedical Sciences, Engineering, Quality Management, or a related scientific discipline.

• Experience working in pharmaceutical, medical device, biotechnology, or other regulated manufacturing environments.

• Familiarity with sterilization processes, validation principles, CAPA, deviation investigations, and nonconformance management.

• Experience with LIMS, MES, Wonderware, Electronic Batch Records, or similar quality systems.

• Knowledge of FDA regulations, including 21 CFR Part 11 and cGMP requirements.

Knowledge & Skills

• Ability to interpret procedures, specifications, and quality documentation.

• Strong written and verbal communication skills with the ability to collaborate cross-functionally.

• Ability to manage multiple priorities in a fast-paced environment.

• Sound judgment in identifying, escalating, and resolving quality-related issues.

• Commitment to quality, compliance, and continuous improvement.

Physical Demands & Work Environment

• Ability to sit, stand, walk, and perform computer-based work throughout the workday.

• Ability to lift up to 20 pounds occasionally.

• Requires visual acuity and attention to detail for review of electronic and paper records.

• Work is performed in office, laboratory, and GMP-regulated manufacturing environments.

• Regular interaction with production operations and manufacturing equipment.

• Moderate noise levels may be present in manufacturing areas.