Quality Assurance Lead- 4th Shift

Quality Assurance Specialist

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Quality Oversight & In-Process Activities

• Perform in-process inspections, audits, sampling, and testing activities in accordance with approved procedures, specifications, and sampling plans.
• Monitor manufacturing processes through routine quality audits and observations to verify compliance with approved procedures and quality requirements.
• Conduct quality inspections using approved methods, equipment, and techniques.
• Perform raw material inspections to verify compliance with established specifications.
• Verify that finished products meet applicable specifications prior to release or disposition.
• Ensure proper handling, identification, and traceability of materials, samples, and quality records throughout the manufacturing process.

Leadership & Training

• Provide day-to-day guidance and technical support to Quality Assurance Technicians and designated manufacturing personnel.
• Assist with onboarding and training of QA Technicians and production associates on quality requirements, inspection methods, sampling practices, GMP, GDP, and applicable procedures.
• Support qualification and ongoing competency assessment of personnel performing quality-related activities.
• Serve as a quality resource for manufacturing operations by promoting compliance and quality awareness.

Deviation Management, Investigations & Escalation

• Identify, document, and escalate nonconformances (NCR(QNs)), deviations, and abnormal conditions through established quality systems.
• Support containment, investigation, and disposition activities associated with nonconforming materials and products.
• Collaborate with Manufacturing, Engineering, and other cross-functional teams to investigate quality issues and support root cause analysis.
• Assist in implementation and follow-up of corrective and preventive actions intended to prevent recurrence of identified issues.
• Provide timely communication and escalation of quality concerns to Quality leadership and impacted functions.

Quality Systems & Continuous Improvement

• Support development, revision, implementation, and maintenance of quality procedures, work instructions, and forms.
• Support compliance with Quality Management System requirements through audits, inspections, and routine monitoring activities.
• Maintain accurate, complete, and contemporaneous quality records in accordance with Good Documentation Practices (GDP).
• Support internal audits, external audits, regulatory inspections, and audit readiness activities.
• Perform statistical analysis, trending, and evaluation of quality data to identify opportunities for improvement and communicate findings to management.
• Prepare and maintain quality metrics, reports, and summaries as required

Compliance & Documentation

• Ensure compliance with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), company policies, and applicable regulatory requirements.
• Execute activities in accordance with approved SOPs, Work Instructions, specifications, and quality standards.
• Maintain required training qualifications and certifications.
• Support data integrity, documentation accuracy, and record retention requirements.

Safety & Compliance

• Demonstrate compliance with site safety requirements and actively support safety initiatives.
• Maintain required safety training and certifications.
• Adhere to all company policies and procedures.
• Perform other duties as assigned to support business needs.

• High School/GED or equivalent required.
• Associate Degree or Technical Degree in a scientific, technical, or related discipline preferred.
• 3+ year of Quality Assurance experience, Preferred

• Ability to work independently with minimal supervision.
• Working knowledge of cGMP, GDP, quality requirements, and…