QA Specialist I

LifeScience Logistics•Brownsburg, IN

11d

About The Position

Provide support during regulatory FDA, DEA, State inspections and customer audits. Plan and present Quality System information to internal and external groups Initiate, review, and approve Change Controls, Recalls, Deviation for nonconformances, & Reactive Maintenance 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, take part in Recall Review/approve product-specific paperwork particular to Client guidelines, Deviations and CAPAs Assist in Operations and Facilities team in determining root cause of discrepancies and help develop corrective actions and verification activities Revise SOPs and WIs for process enhancement Perform Gemba walk applies six sigma concepts such as 5S’s 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 Take part on ISM (Inventory System Management) after hours rotation program Assist in validation projects Being able to be on call for WebCTRL temperature monitoring on a rotation program Assist in generating and reviewing temperature monthly reports in a timely manner Other duties as assigned

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
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
Take ownership
High standard
Training – public speaking
Ability to take Constructive Criticism
Interest in working in a fast-paced environment
Deftly navigate through Quality and Warehouse Management Systems with training – COMPLIANCE QUEST, Tecsys Elite, WebCTRL
Intermediate Microsoft Office skills: Outlook, Excel, PowerPoint
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

Strong understanding of a 3PL business, audits and complaints procedures is preferred
Validation and DEA experience strongly preferred
Medical Device, Pharma, and Plasma experience preferred
Experience in temperature monitoring of controlled environments
Certified auditor training per ASQ or ISO (preferred)
Demonstrated skills and practice of Six Sigma/statistics and process capability/FMEA is preferred

Responsibilities

Provide support during regulatory FDA, DEA, State inspections and customer audits.
Plan and present Quality System information to internal and external groups
Initiate, review, and approve Change Controls, Recalls, Deviation for nonconformances, & Reactive Maintenance
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, take part in Recall
Review/approve product-specific paperwork particular to Client guidelines, Deviations and CAPAs
Assist in Operations and Facilities team in determining root cause of discrepancies and help develop corrective actions and verification activities
Revise SOPs and WIs for process enhancement
Perform Gemba walk applies six sigma concepts such as 5S’s
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
Take part on ISM (Inventory System Management) after hours rotation program
Assist in validation projects
Being able to be on call for WebCTRL temperature monitoring on a rotation program
Assist in generating and reviewing temperature monthly reports in a timely manner
Other duties as assigned