Ld Tech, Quality Assurance

Responsible for providing day-to-day quality oversight and technical leadership to support manufacturing operations. Performs quality inspections process audits sampling testing and quality system activities to ensure products meet established specifications regulatory requirements and quality standards.

This role supports manufacturing operations by providing quality guidance training investigation support nonconformance management and oversight of activities to ensure compliance with GMP GDP and Quality System requirements.

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

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 (Client(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 Diploma/GED required.

Associate Degree or Technical Degree in a scientific technical or related discipline preferred.

3 years of Quality Assurance experience preferred.

Knowledge and Skills:

Working knowledge of cGMP GDP Quality Systems and regulatory requirements.

Experience conducting inspections audits and quality-related activities in a manufacturing environment.

Strong analytical problem-solving and troubleshooting skills.

Proficiency in Microsoft Office applications particularly Excel.

Ability to interpret specifications procedures and technical documentation.

Strong communication organizational and leadership skills.

Ability to identify evaluate and escalate quality issues appropriately.