Quality Assurance Specialist Job Irving area,Texas USA,Quality Assurance

Position: Quality Assurance Specialist I

Provide support during regulatory FDA, DEA, State inspections and customer audits.
Plan and present Quality System information to internal and external groups
Initiate, review, and approve Change Controls, Recalls, Deviation for nonconformances, & Reactive Maintenance
Work to maintain Quality Systems policies and procedures to ensure regulatory compliance
Be a part of the internal audit team and assist in external audits
Release “quarantined” product upon receipt of documentation from Client and use Hold and Release process, take part in Recall
Review/approve product-specific paperwork particular to Client guidelines, Deviations and CAPAs
Assist in Operations and Facilities team in determining root cause of discrepancies and help develop corrective actions and verification activities
Revise SOPs and WIs for process enhancement
Perform Gemba walk applies six sigma concepts such as 5S’s
Participate in cross-functional initiatives for a 3PL environment
Strong leadership skills and logistics (3PL) knowledge
Able to professionally communicate with customers/clients
Assist in returns and damages process
Perform record reviews to ensure compliance with all applicable procedures and regulations
Take part on ISM (Inventory System Management) after hours rotation program
Assist in validation projects
Being able to be on call for WebCTRL temperature monitoring on a rotation program
Assist in generating and reviewing temperature monthly reports in a timely manner
Other duties as assigned

Responsibilities

Provide support during regulatory FDA, DEA, State inspections and customer audits.
Plan and present Quality System information to internal and external groups
Initiate, review, and approve Change Controls, Recalls, Deviation for nonconformances, & Reactive Maintenance
Work to maintain Quality Systems policies and procedures to ensure regulatory compliance
Be a part of the internal audit team and assist in external audits
Release “quarantined” product upon receipt of documentation from Client and use Hold and Release process, take part in Recall
Review/approve product-specific paperwork particular to Client guidelines, Deviations and CAPAs
Assist in Operations and Facilities team in determining root cause of discrepancies and help develop corrective actions and verification activities
Revise SOPs and WIs for process enhancement
Perform Gemba walk applies six sigma concepts such as 5S’s
Participate in cross-functional initiatives for a 3PL environment
Strong leadership skills and logistics (3PL) knowledge
Able to professionally communicate with customers/clients
Assist in returns and damages process
Perform record reviews to ensure compliance with all applicable procedures and regulations
Take part on ISM (Inventory System Management) after hours rotation program
Assist in validation projects

Being able to be on call for WebCTRL temperature monitoring on a rotation program
Assist in generating and reviewing temperature monthly reports in a timely manner
Other duties as assigned

Qualifications And Job Specifications

Bachelor of Science (BS) degree in Engineering, Science, Logistics, or related field preferred
Minimum of 1-3 years’ experience in a quality, preferably a logistics role
Strong understanding of a 3PL business, audits and complaints procedures is preferred
Validation and DEA experience strongly preferred
Medical Device, Pharma, and Plasma experience preferred
Experience in temperature monitoring of controlled environments
Demonstration of the following:
Effective time management skills
Impeccable verbal and written communication skills
Ability to conduct appropriate research as needed
Strong presentation skills
Attention to detail and organization
Critical thinking
Take ownership
High standard
Training – public speaking
Ability to take Constructive Criticism
Interest in working in a fast‑paced environment

Technical Expertise

Deftly navigate through Quality and Warehouse Management Systems with training – COMPLIANCE QUEST, Tecsys Elite, WebCTRL
Intermediate Microsoft Office skills:
Outlook, Excel, Power Point
Certified auditor training per ASQ or ISO (preferred)
Demonstrated skills and practice of Six Sigma/statistics and process capability/FMEA is…