Quality Assurance Specialist II

Life Science Logistics•Brownsburg, IN

2d•Hybrid

About The Position

The Quality Assurance Specialist II will be responsible for reviewing and approving various quality-related documents and processes, ensuring compliance with established procedures and regulations. This role involves active participation in internal and external audits, assisting with the DEA program, and contributing to process improvement initiatives. The specialist will also interact with regulatory agencies and clients, present quality system information, and manage quality files. Additionally, this position will perform holds and releases, monitor inventory adjustments, and conduct training on quality documents.

Requirements

Bachelor of Science (BS) degree in Engineering, Science, or related field preferred
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
Medical Device, Pharma and DEA experienced preferred
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
Certified auditor training per ASQ or ISO (preferred)
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
Certified auditor training per ASQ or ISO
Medical Device, Pharma and DEA experienced

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