Job Title: Ld Tech, Quality Assurance
Location: El Paso Texas 79912
Job Responsibilities
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 elevate 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 elevate quality issues appropriately.