Quality Assurance Specialist II

LifeScience Logistics•Brownsburg, IN

3d•Hybrid

About The Position

This role involves reviewing and approving various quality-related documents and processes, assisting with validations, maintaining quality files, and ensuring facility compliance. The specialist will participate in internal and external audits, support the DEA program, and collaborate with various departments and agencies to uphold company quality standards. Key responsibilities include performing holds and releases, assisting with returns, damage, and recall processes, reviewing inventory adjustments, identifying unusual trends, and conducting training on quality documents.

Requirements

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

Nice To Haves

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)

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