Quality Assurance Specialist II

Job TitleJob DescriptionResponsibilitiesProvide support during regulatory FDA, DEA, State inspections and customer audits.Plan and present Quality System information to internal and external groupsInitiate, review, and approve Change Controls, Recalls, Deviations for nonconformances, & Reactive MaintenanceWork to maintain Quality Systems policies and procedures to ensure regulatory complianceBe a part of the internal audit team and assist in external auditsRelease "quarantined" product upon receipt of documentation from Client and use Hold and Release process, take part in RecallReview/approve product-specific paperwork particular to Client guidelines, Deviations and CAPAsAssist in Operations and Facilities team in determining root cause of discrepancies and help develop corrective actions and verification activitiesRevise SOPs and WIs for process enhancementPerform Gemba walk applies six sigma concepts such as 5S'sParticipate in cross-functional initiatives for a 3PL environmentStrong leadership skills and logistics (3PL) knowledgeAble to professionally communicate with customers/clientsAssist in returns and damages processPerform record reviews to ensure compliance with all applicable procedures and regulationsTake part on ISM (Inventory System Management) after hours rotation programAssist in validation projectsBeing able to be on call for WebCTRL temperature monitoring on a rotation programAssist in generating and reviewing temperature monthly reports in a timely mannerOther duties as assignedQualifications and Job SpecificationsBachelor of Science (BS) degree in Engineering, Science, Logistics, or related field preferredMinimum of 1-3 years' experience in a quality, preferably a logistics roleStrong understanding of a 3PL business, audits and complaints procedures is preferredValidation and DEA experience strongly preferredMedical Device, Pharma, and Plasma experience preferredExperience in temperature monitoring of controlled environmentsDemonstration of the following:Effective time management skillsImpeccable verbal and written communication skillsAbility to conduct appropriate research as neededStrong presentation skillsAttention to detail and organizationCritical thinkingTake ownershipHigh standardTraining – public speakingAbility to take Constructive CriticismInterest in working in a fast-paced environmentTechnical ExpertiseDeftly navigate through Quality and Warehouse Management Systems with training – COMPLIANCE QUEST, Tecsys Elite, WebCTRLIntermediate Microsoft Office skills: Outlook, Excel, PowerPointCertified auditor training per ASQ or ISO (preferred)Demonstrated skills and practice of Six Sigma/statistics and process capability/FMEA is preferredConversant with cGMPs, Quality Systems and CAPAs per 21 CFR 210/211 and 820Verifiable aptitude of FDA, OSHA, and DEA regulationsIntermediate public speaking and presentation skillsExcellent verbal and written communication skillsAdditional Employment RequirementsMust 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 licensePhysical/Mental/Visual DemandsWork is light to medium in nature with frequent walking to perform assigned tasksMust be able to safely conduct occasional lifting of 25 - 50 lbs.Ability to handle multiple priorities and solve inquiries and issues expeditiously and efficientlyMust be able to read at a distance, close to the eyes, and at arm's length with or without correction.Working ConditionsActivities occur within a typical office environment25% of time is spent in a warehouse settingEquipment OperatedEquipment: Laptop computer, cell phone,copier, and desk phoneSystems: 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*Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.