Sr. Quality Assurance Specialist

supply-chain; Grand Prairie (TX); On-site; USD 70,000 - 115,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Prescription

Discounted Stock Purchase

General Bonus Plan

Generous PTO

Job summary

DHL Supply Chain is seeking a Sr. QA Specialist to oversee quality systems across multiple sites in the United States.

You will lead CAPA management, internal audits, and regulatory compliance efforts while coordinating licenses, training, and documentation to ensure adherence to FDA, GxPs, and related standards. The role requires a Bachelor degree with 4+ years in a regulated environment or ISO 9001 expertise, plus strong data analysis and leadership skills.

Qualifications

• Bachelor Degree or equivalent 4 years work experience, required
• Certification related to quality control, preferred
• 2+ years experience in a regulated environment OR ISO 9001 compliant or certified, required
• Manufacturing, Food, Life Sciences, or 3PL Industry experience, required
• Supervising or implementing quality control
• Working knowledge of regulations such as FDA, GxPs, ATF, DEA, etc.
• Administrator of training in compliance to regulated standards
• People management
• Sufficient computer application experience
• Strong written and verbal communication
• Data analysis experience
• Training and facilitation skills
• Self management
• Problem solving
• Project management
• Presenting
• Report creation

Responsibilities

• Supervise the maintenance and continuous improvement of the overall quality system, including management review, CAPA management, internal quality audits, quality self-assessments, change control, document control, and standard operating procedures/work instructions.
• Coordinate select licenses, permits, and registrations.
• Analyze information and product specifications to determine regulatory compliance with regards to products handled and services performed at the site.
• Lead select key regulatory, customer and 3rd party audits.
• Monitor the training and development of site associates to ensure compliance to processes and regulations
• Manage Quality Technicians within the site, as applicable. Track and maintain quality assurance metrics for the organization.
• Act as a customer contact for QA related issues/initiatives as needed.
• Partner with QA management to develop, distribute and maintain regular management reports.
• Read, interpret, and communicate technical documents, and regulations.
• Maintain site CAPA system for handling complaints and non-conformances
• Write and maintain work instructions, SOPs, and customer specific processes and ensure team is trained on applications
• Maintain document and change control with all regulated documents

Skills

Quality Assurance

Regulatory Compliance

Data Analysis

Project Management

Training & Facilitation

People Management

Communication

Problem Solving

Education

Bachelor Degree

Quality-related Certification

Job description

The Sr. QA Specialist role has a national salary range of $70,000 - $115,000.

For roles within California the range is $70,304 - $115,000 and Washington is $80,169 - $115,000.

DHL Supply Chain offers multiple benefits including Medical, Dental, Vision, Prescription, Discounted Stock Purchase, General Bonus Plan and a generous PTO policy.

Are you looking for a challenging and rewarding opportunity in a fast-paced environment? Do you take an analytical approach to design complex and innovative solutions that exceed customer expectations and directly impact a growing business? Do you enjoy being part of a passionate team that works with stakeholders from across the business to create and implement the best solutions for our customers?

Job Description

Support the planning and coordination of all aspects of quality assurance activities with various levels of risk and complexity within a variety of scopes at the site or multi site level. Responsible for requests for quality support from the site and communicates policies and procedures. The subject matter expert regarding selected governmental regulations for the site(s). Act as the primary quality assurance customer contact for the site.

• Supervise the maintenance and continuous improvement of the overall quality system, including management review, CAPA management, internal quality audits, quality self-assessments, change control, document control, and standard operating procedures/work instructions.
• Coordinate select licenses, permits, and registrations.
• Analyze information and product specifications to determine regulatory compliance with regards to products handled and services performed at the site.
• Lead select key regulatory, customer and 3rd party audits.
• Monitor the training and development of site associates to ensure compliance to processes and regulations
• Manage Quality Technicians within the site, as applicable. Track and maintain quality assurance metrics for the organization.
• Act as a customer contact for QA related issues/initiatives as needed.
• Partner with QA management to develop, distribute and maintain regular management reports.
• Read, interpret, and communicate technical documents, and regulations.
• Maintain site CAPA system for handling complaints and non-conformances
• Write and maintain work instructions, SOPs, and customer specific processes and ensure team is trained on applications
• Maintain document and change control with all regulated documents

Required Education and Experience

• Bachelor Degree or equivalent 4 years work experience, required
• Certification related to quality control, preferred
• 2+ years experience in a regulated environment OR ISO 9001 compliant or certified, required
• Manufacturing, Food, Life Sciences, or 3PL Industry experience, required
• Supervising or implementing quality control
• Working knowledge of regulations such as FDA, GxPs, ATF, DEA, etc.
• Administrator of training in compliance to regulated standards
• People management
• Sufficient computer application experience
• Strong written and verbal communication
• Data analysis experience
• Training and facilitation skills
• Self management
• Problem solving
• Project management
• Presenting
• Report creation

Our Organization is an equal opportunity employer.