IT Quality Compliance Specialist/Analyst

100% onsite 1. PURPOSE AND SCOPE OF POSITION: The LSM(Lab Systems Management) Equipment Engineer supports the successful operation of laboratory and clinical manufacturing operations at their home sites through interaction with internal team members and internal customers, and external service providers. The incumbent conducts tasks assigned by the management independently or with minimum supervision. The LSM Equipment Engineer is responsible for initiating and owning deviations, CAPAs, and change controls, and authoring calibration and maintenance SOPs as well as performing calibrations, maintenance, and qualifications/validations. 2. REQUIRED COMPETENCIES: Knowledge of cGMP and good documentation practices. Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment. Knowledge of calibration management and environmental monitoring systems. Strong critical thinking skills and the ability to work independently. Excellent interpersonal and communication skills with experience dealing with a diverse workforce where individual initiative, accountability to the team, and professional maturity are required. Strong multi-tasking and organizational ability. Ability to effectively manage multiple tasks and activities simultaneously. Proficiency in Microsoft Office Suite – Word, Excel, PowerPoint, and Outlook; innate ability to learn new software, such as corporate intranet and enterprise applications. Working knowledge of scheduling software and systems, and inventory management systems, Blue Mountain RAM and Maximo preferred. Ability to interact effectively with QC, Manufacturing, QA, and Facilities groups. 3. DUTIES AND RESPONSIBILITIES Operational Activities Executes equipment calibration, preventative maintenance, performance verification and repair activities in laboratory and manufacturing areas. Supervises vendors for calibration, preventative maintenance, performance verification and repair functions. Reviews and approves vendor executed calibration, maintenance, repair, and performance verification records for accuracy, and completeness. Ensures all calibration, PM, and performance verification records are filed appropriately after approval. Executes requalification on Controlled Temperature Units (ex. Refrigerators, Freezers (which includes -20°C / -80°C Freezers), Incubators, Cryotanks, and Cryopods). Supports multiple sites within Warren and Summit. Owns and supports deviations and investigations that result from calibration or performance verification activities, along with developing and supporting the implementation of corrective and preventive actions. Authors and supports the development, revision, and review of written procedures for calibration, preventive maintenance, and performance verification of equipment. Support the development, review and approval of calibration and maintenance plans in site CMMS system. Supports the execution of process improvement studies, as required. Adheres to written policies and procedures governing the LSM department activities and the equipment they manage to ensure compliance with approved standards. Maintains a positive relationship with the site customers and outside vendors while promoting a positive team environment. Follows cGMP (current Good Manufacturing Practices) and ALCOA principles ('ALCOA' defines that data should be Attributable, Legible, Contemporaneous, Original, and Accurate) In addition, 'ALCOA+' guidance recommends that data is also Complete, Consistent, Enduring, and Available. Inventory Management Work with Planning group to ensure system is updated as calibration, maintenance and performance verification activities are performed. Approves Change Request, Asset Inductions, and Work Request. Approving Calibration and Maintenance forms. Perform Client's investigations. Review and approve calibration and maintenance work. Regulatory Responsibilities Maintains all required Corporate, Facilities and EHS training as required. Adheres to all safety procedures and hazard communication. May be called upon to act as SME in both internal and regulatory audits. 4. EDUCATION AND EXPERIENCE BS in Engineering or Science related discipline required Minimum 2 years of experience in FDA-regulated industry. Minimum 3 years of experience working directly with laboratory equipment (ex. centrifuges, temperature/humidity meters, balances, freezers, refrigerators etc.) Maintenance coordination / planning experience preferred. Experience working in a clinical environment preferred. 5. WORKING CONDITIONS: Physical / Mental Demands: Occasional stooping, bending, stretching, pushing, pulling, reaching, and/or lifting up to 25 lbs. Ability to sit, stand, walk, and move within workspace for extended periods. Ability to perform repetitive tasks, including hand to finger manipulations, grasping, pushing, and pulling. Environmental Conditions: Environment may include working in office, laboratory, or manufacturing area. Donning proper gowning and/or PPE such as safety glasses and shoes in an environment with hazardous materials and waste will be required. Working safely and effectively when working alone or working with others will be required. #J-18808-Ljbffr