Quality Assurance Specialist I

Life Science Logistics•Puyallup, WA

2d•Hybrid

About The Position

This role provides support during regulatory inspections and customer audits, plans and presents Quality System information, and initiates, reviews, and approves various quality-related documents such as Change Controls, Recalls, and Deviations. The specialist will maintain Quality Systems policies and procedures to ensure regulatory compliance, participate in internal and external audits, and release quarantined product. Responsibilities also include reviewing product-specific paperwork, assisting in root cause analysis and corrective action development, revising SOPs and WIs, performing Gemba walks applying Six Sigma concepts, and participating in cross-functional initiatives within a 3PL environment. The role requires strong leadership and logistics knowledge, professional customer communication, assistance with returns and damages, record reviews for compliance, participation in after-hours ISM rotation, assisting in validation projects, and being on call for WebCTRL temperature monitoring with monthly report generation.

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.
Work is light to medium in nature with frequent walking to perform assigned tasks.
Must be able to safely conduct occasional lifting of 25 - 50 lbs.
Ability to handle multiple priorities and solve inquiries and issues expeditiously and efficiently.
Must be able to read at a distance, close to the eyes, and at arm’s length with or without correction.

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.
Intermediate public speaking and presentation skills.

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.
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.