Quality Assurance Specialist II

RESPONSIBILITIES:Reviews and approves Change Requests, Reactive Maintenance, Deviations/CAPA as assignedAssist with validations as assignedReview records and forms to ensure compliance with established LSL procedures and regulationsMaintain Quality files as applicable: Scan, Save to appropriate online storage, filePerform warehouse walkthroughs to ensure the facility is maintained in a clean, safe, compliant mannerBe a part of the internal audit team and assist in external auditsAssist with the DEA programAssist QA Supervisor and CQCU in developing plans and programs for process improvementInteract with state and federal agencies, clients, and corporate quality groupPlan and present Quality System information to internal and external groupsWork with Quality Systems and all levels of facility personnel to achieve company quality standardsPerform Holds and Releases as directed by clients which can include temptale downloads as neededAssist in the Returns, Damage and Recall processesReview and approve inventory adjustmentsNotify QA Supervisor and CQCU of any unusual trendsPerform training on Quality related documents when necessaryOther duties as assignedQUALIFICATIONS AND JOB SPECIFICATIONS:Bachelor of Science (BS) degree in Engineering, Science, or related field preferredMinimum of 1-3 years’ experience in a quality role, preferably in a logistics setting Conversant with cGMPs, Quality Systems, and CAPAsStrong understanding of a 3PL business, audits and complaints proceduresMedical Device, Pharma and DEA experienced preferredKnowledge of electronic document systemsDemonstration 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, andInterest in working in a fast-paced environmentTECHNICAL EXPERTISE:Deftly navigate through Quality and Warehouse Management Systems with training – MQ1, 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/FMEAConversant 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 skills ADDITIONAL EMPLOYMENT REQUIREMENTSMust be able to successfully pass all preliminary employment requirements (ie. background check and drug screen)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 lbsAbility 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 will be spent in a warehouse setting15 % of time will be spent on key entry EQUIPMENT OPERATEDEquipment: Laptop computer, cell phone, fax machine, copier, and desk phoneSystems: Outlook, Excel, Word, PowerPoint, WebCTRL (Temperature Monitoring Software), TECSYS (WMS – Warehouse Management System), and MQ1 (Quality Management Software)