Job Description
Job Description
Responsibilities
- Manage Processes : Change Requests, Reactive Maintenance, Deviations / CAPA
- Direct, mentor, train and coach direct reports
- Manage Vendor Qualification program
- Assist with validation of temperature controlled warehouse
- Participate in internal and external audits
- Assist with DEA program
- Interact with state and federal agencies, clients, and corporate quality group
- Work with Quality Systems, policies and procedures and all levels of facility personnel to achieve company quality standards and to ensure regulatory compliance
- Develop and maintain broad knowledge of technical disciplines in own functional area(s) and apply broad knowledge of trends
- Lead change initiatives by identifying best approach for implementing strategic processes
- Assist with Holds and Releases as directed by clients
- Review inventory adjustments for trends
- Help guide Operations team in determining root cause of discrepancies and help develop corrective actions and verification activities
- Notify Operations Managers and CQCU of any unusual trends
- Make suggestions on Quality improvements
- Perform training on Quality related documents when necessary
- Other duties as assigned
Qualifications and Job Specifications
Bachelor of Science (BS) degree in Engineering, Science, or related field (preferred)Minimum of 1-3 years’ experience in warehousing or 3PL environmentMinimum of 3 – 5 years in Quality in the medical device and / or pharmaceutical or other regulated industryDemonstration 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 – CQ, Tecsys Elite, WEBCTRLIntermediate Microsoft Office skills : Outlook, Excel, PowerPointStrong knowledge of cGMPs, Quality Systems and CAPAs per 21 CFR 210 / 211 and 820Verifiable aptitude of FDA and DEA regulationsCertified auditor training per ASQ or ISO (preferred)Intermediate public speaking and presentation skillsAbility to maintain and track budget / spending trendsExcellent verbal and written communication skillsAdditional Employment Requirements
Must be able to successfully pass all preliminary employment requirementsMust have a valid driver’s licenseMust be able to travel up to 30%Physical / Mental / Visual Demands
Work is light to medium in nature with frequent walking to perform assigned tasksMust be able to safely conduct occasional lifting of 25 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 correctionWorking Conditions
Activities occur within a typical office environment20% of time will be spent in a warehouse settingEquipment Operated
Equipment : Laptop computer, cell phone, copierSystems : Outlook, Excel, Word, PowerPoint, WebCTRL (Temperature Monitoring Software), TECSYS (WMS – Warehouse Management System), and CQ (Quality Management Software)LifeScience Logistics is an equal opportunity employer that takes affirmative action to employ and advance in employment individuals without regard to race, color, religion, sex, national origin, protected veteran status, disability, sexual orientation, gender identity, or any other federal, state, or local protected class.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
NO AGENCIES PLEASE