Quality Assurance Specialist I

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

Qualifications and Job Specifications

• 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
• 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
• Demonstration of the following:
• 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

Technical Expertise

• Deftly navigate through Quality and Warehouse Management Systems with training – COMPLIANCE QUEST, Tecsys Elite, WebCTRL
• Intermediate Microsoft Office skills: Outlook, Excel, PowerPoint
• Certified auditor training per ASQ or ISO (preferred)
• Demonstrated skills and practice of Six Sigma/statistics and process capability/FMEA is preferred
• 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

Additional Employment Requirements

• 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

Physical/Mental/Visual Demands

• 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.

Working Conditions

• Activities occur within a typical office environment
• 25% of time is spent in a warehouse setting

Equipment Operated

• Equipment: Laptop computer, cell phone,copier, and desk phone
• Systems: Outlook, Excel, Word, PowerPoint, WebCTRL (Temperature Monitoring Software), TECSYS (WMS – Warehouse Management System), and COMPLIANCE QUEST (Quality Management Software)

* NO AGENCIES PLEASE *