Quality Assurance Specialist II

Life Science Logistics•Memphis, TN

3d•Hybrid

About The Position

This role involves supporting regulatory inspections and customer audits, planning and presenting Quality System information, and maintaining Quality Systems policies and procedures to ensure regulatory compliance. The specialist will be part of the internal audit team, assist in external audits, and release quarantined product. They will also review and approve product-specific paperwork, help guide the Operations team in determining root causes of discrepancies, and develop corrective actions. Additionally, the role includes reviewing and approving Deviations and CAPAs, making suggestions for Quality improvements, 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 role also involves assisting in the returns and damages process and performing record reviews to ensure compliance.

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.
Demonstration of 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.
Interest in working in a fast-paced environment.
Deftly navigate through Quality and Warehouse Management Systems with training – MQ1, Tecsys Elite, WebCTRL.
Intermediate Microsoft Office skills: Outlook, Excel, PowerPoint.
Demonstrated skills and practice of Six Sigma/statistics and process capability/FMEA.
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

Validation and DEA experience strongly preferred.
Medical Device, Pharma, and Plasma experience preferred.
Certified auditor training per ASQ or ISO (preferred).

Responsibilities

Provide support during regulatory inspections and customer audits.
Plan and present Quality System information to internal and external groups.
Demonstrate expert knowledge of Quality Systems.
Familiar with Change Controls.
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.
Review/approve product-specific paperwork particular to Client guidelines.
Help guide Operations team in determining root cause of discrepancies and help develop corrective actions and verification activities.
Review and approve Deviations and CAPAs.
Make suggestions on Quality improvements.
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.
Other duties as assigned.