Quality Assurance Lead- 4th Shift

We are the people who give possibilities purpose

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.

Job Responsibilities: (Primary Duties, Roles, and/or Authorities)

Qu
ality 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 elevate 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.

Education and Experience:

• 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

Knowledge and

Skills:

• Ability to work independently with minimal supervision.
• Working knowledge of cGMP, GDP, quality requirements, and applicable regulatory standards.
• Experience enforcing SOPs, specifications, and quality requirements.
• Proficiency in Microsoft Excel and basic data analysis.
• Strong mathematical, analytical, and problem-solving skills.
• Experience using measuring and inspection…