LifeScience Logistics · 1 month ago
Quality Assurance Specialist II
Apex, NC
Full-time
Onsite
Entry, Mid Level
1+ years expLifeScience Logistics is a company focused on providing logistics solutions in the life sciences sector. They are seeking a Quality Assurance Specialist II to ensure compliance with quality standards and assist in various quality-related processes within the organization.
Health CareLogisticsSupply Chain Management
Responsibilities
Reviews and approves Change Requests, Reactive Maintenance, Deviations/CAPA as assigned
Assist with validations as assigned
Review records and forms to ensure compliance with established LSL procedures and regulations
Maintain Quality files as applicable: Scan, Save to appropriate online storage, file
Perform warehouse walkthroughs to ensure the facility is maintained in a clean, safe, compliant manner
Be a part of the internal audit team and assist in external audits
Assist with the DEA program
Assist QA Supervisor and CQCU in developing plans and programs for process improvement
Interact with state and federal agencies, clients, and corporate quality group
Plan and present Quality System information to internal and external groups
Work with Quality Systems and all levels of facility personnel to achieve company quality standards
Perform Holds and Releases as directed by clients which can include temptale downloads as needed
Assist in the Returns, Damage and Recall processes
Review and approve inventory adjustments
Notify QA Supervisor and CQCU of any unusual trends
Perform training on Quality related documents when necessary
Other duties as assigned
Qualification
Required
Bachelor of Science (BS) degree in Engineering, Science, or related field
Minimum of 1-3 years' experience in a quality role, preferably in a logistics setting
Conversant with cGMPs, Quality Systems, and CAPAs
Strong understanding of a 3PL business, audits and complaints procedures
Knowledge of electronic document systems
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 (ie. background check and drug screen)
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
Preferred
Bachelor of Science (BS) degree in Engineering, Science, or related field preferred
Medical Device, Pharma and DEA experienced preferred
Certified auditor training per ASQ or ISO (preferred)
Company
LifeScience Logistics
LifeScience Logistics is a logistics company offering healthcare supply chain solutions.
501-1000 employees
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
Blackstone Group
2021-11-16Private Equity
Leadership Team
David Allen
Chief Financial Officer
Jonah Petchesky
Partner
Recent News
2025-06-23
Company data provided by crunchbase