Quality Assurance Supervisor

Life Science Logistics•Clayton, IN

11d

About The Position

Manages Processes: Change Requests, Reactive Maintenance, Deviation/CAPA. Direct, mentor, train and coach direct reports to support their career goals and LSL pipeline. Support Vendor Qualification program Support temperature-controlled warehouse requiring scheduled on call duties (minimal). Participate and support Internal audit program. Assist with DEA program as applicable. Lead interface with state, federal, ISO and LSL clients for all unannounced and/or scheduled audits at the facility. Work with Quality systems, policies and procedures and all levels of facility personnel to achieve company standards and to ensure regulatory compliance. Assist with Holds and Releases as directed by clients. Support department teams to determine root cause of discrepancies and assist with developing corrective actions and verification activities as needed. Lead change initiatives by identifying best approach for implementing strategic processes. Support Quality Management Review process by collecting required QA metrics and highlighting adverse trends. This position does provide quality oversight and review of the sampling & dispensing cleanroom generated paperwork. Perform training on Quality related documents when necessary Other duties as assigned.

Requirements

Bachelor of Science (B.S.) degree in Engineering, Science or related field (preferred)
Minimum of 3-5 years of experience in Quality in the medical device or pharmaceutical or other regulated industry
A minimum of two (2) years supervisory experience
Effective time management skills
Impeccable verbal and written communication skills
Ability to conduct appropriate research as needed
Strong presentation skills
Strong analytical skills for safety and compliance
Attention to detail and organization
Critical thinking
Interest to work in a fast-paced environment
Navigate through Quality and Warehouse Management Systems with training – CQ, Tecsys Elite, WebCTRL
Intermediate Microsoft Office skills: Outlook, Excel, PowerPoint
Strong knowledge of cGMPs, Quality Systems and CAPAs per 21 CFR 210/211 and 820
Verifiable aptitude of FDA regulations
Intermediate public speaking and presentation skills
Ability to track and present quality metrics/trends
Must be able to successfully pass all preliminary employment requirements (i.e., background check and drug screen)
Must be able to travel < 10%
Must have a valid driver’s license
Must be able to safely conduct occasional lifting of 25 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 lengthwith or without correction

Nice To Haves

ASQ and/or ISO Auditor Certifications preferred

Responsibilities

Manages Processes: Change Requests, Reactive Maintenance, Deviation/CAPA
Direct, mentor, train and coach direct reports to support their career goals and LSL pipeline
Support Vendor Qualification program
Support temperature-controlled warehouse requiring scheduled on call duties (minimal)
Participate and support Internal audit program
Assist with DEA program as applicable
Lead interface with state, federal, ISO and LSL clients for all unannounced and/or scheduled audits at the facility
Work with Quality systems, policies and procedures and all levels of facility personnel to achieve company standards and to ensure regulatory compliance
Assist with Holds and Releases as directed by clients
Support department teams to determine root cause of discrepancies and assist with developing corrective actions and verification activities as needed
Lead change initiatives by identifying best approach for implementing strategic processes
Support Quality Management Review process by collecting required QA metrics and highlighting adverse trends
This position does provide quality oversight and review of the sampling & dispensing cleanroom generated paperwork
Perform training on Quality related documents when necessary
Other duties as assigned