Quality Assurance Specialist I

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. 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). LifeScience Logistics is an equal opportunity employer. Candidates will not be hired based on their race, sex, color, religion or national origin. Reasonable accommodations are available for individuals with disabilities. We proudly support the employment of veterans and welcome applications from protected veterans and all qualified applicants. NO AGENCIES PLEASE* #J-18808-Ljbffr