Quality Assurance Specialist I

Life Science Logistics•Irving, TX

31d•Hybrid

About The Position

The Quality Assurance Specialist I will provide support during regulatory FDA, DEA, State inspections and customer audits. This role involves planning and presenting Quality System information, initiating, reviewing, and approving Change Controls, Recalls, Deviations for nonconformances, and Reactive Maintenance. The specialist will work to maintain Quality Systems policies and procedures to ensure regulatory compliance, participate in the internal audit team, and assist in external audits. Key responsibilities include releasing quarantined product, participating in Recall Review, approving product-specific paperwork, and assisting Operations and Facilities teams in determining root causes of discrepancies and developing corrective actions. The role also involves revising SOPs and WIs for process enhancement, performing Gemba walks applying Six Sigma concepts, and participating in cross-functional initiatives within a 3PL environment. Strong leadership skills and logistics (3PL) knowledge are essential, as is the ability to professionally communicate with customers/clients. The specialist will also assist in the returns and damages process, perform record reviews for compliance, and participate in the ISM (Inventory System Management) after-hours rotation program. Additionally, the role supports validation projects, participates in a WebCTRL temperature monitoring on-call rotation, and assists in generating and reviewing monthly temperature reports. Other duties as assigned.

Requirements

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.
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.
Deftly navigate through Quality and Warehouse Management Systems with training – COMPLIANCE QUEST, Tecsys Elite, WebCTRL.
Intermediate Microsoft Office skills: Outlook, Excel, PowerPoint.
Certified auditor training per ASQ or ISO (preferred).
Demonstrated skills and practice of Six Sigma/statistics and process capability/FMEA is preferred.
Conversant with cGMPs, Quality Systems and CAPAs per 21 CFR 210/211 and 820.
Verifiable aptitude of FDA, OSHA, and DEA regulations.
Intermediate public speaking and presentation skills.
Excellent verbal and written communication skills.
Must be able to successfully pass all preliminary employment requirements (i.e., background check and drug screen).
Must be able to travel up to 10%.
Must have a valid driver’s license.

Nice To Haves

Bachelor of Science (BS) degree in Engineering, Science, Logistics, or related field.
Strong understanding of a 3PL business, audits and complaints procedures.
Validation and DEA experience.
Medical Device, Pharma, and Plasma experience.
Certified auditor training per ASQ or ISO.
Demonstrated skills and practice of Six Sigma/statistics and process capability/FMEA.

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, Deviations 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.