Validation Specialist NWN Corporation - Clayton, NC $48 - $53 an hour NWN is recognized as one of the top 16 Cisco partners in the U.S. and a leader in the IT services industry with many awards and elite certifications from Hewlett Packard, NetApp, EMC, Microsoft and VMware to name only a few. With over 600 employees in 12 locations across the U.S. the company is on a fast track to even greater success. If you're a top performer looking for a new opportunity we want to talk to you! NWN is currently seeking a Validation Specialist on behalf of our esteemed client in Clayton, NC. This is a mid-level, 6-12 Month Contract opportunity with a competitive rate and full benefits package. General Scope & Position Purpose: * Quality review & approval of validation activities associated with changes to existing & new systems. * Ensure that validation processes are preformed according to relevant procedures & instructions. * Challenge validation activities & content of the validation documentation to assure compliance & quality. * Processes include formulation, sterilization, cleaning, filling, QC, clean utilities, warehouse, inspection, packaging & assembly. Essential Duties and Responsibilities: * Perform, review & approve validation & PSE activities. * Review & approve documents in accordance with local, corporate & regulatory regulations. * Collaborate, review & approve IQ, OQ & PQ protocols for direct impact systems/processes per approved timeframes. * Supports &/or leads the closure of investigations per approved timeframes using root cause analysis techniques. * Participate in teams to help identify root causes of failures & implement corrective actions which address & eliminate potential reoccurrence of the failures. * Ensure executed protocol data reviewed is accurate & meets documented acceptance criteria. * Quality review & approval of Change Requests (CR's) related to validation activities for the site. * Review & approve validation procedures, specifications & quality documents for accuracy & compliance. * Presentation & support for validation concepts & approaches with audits & inspections. * Follow all safety & environmental requirements in the performance of duties. Qualifications: * BA/BS in a Computer Science, Engineering, Biology, Chemistry, or other related field * Minimum 2 years validation or quality related discipline experience in pharmaceutical or medical device industry. * Experience in quality concepts including technical & compliance review of validation & quality documents. * Experience in one or more core validation areas (sterilization, packaging, cleaning, utilities, packaging, process, or computer validation). * Experience in cGMP documentation practices & regulations. * Requires a minimum of 1 year of experience in reviewing GMP documents for compliance purposes. * Demonstrated expertise in planning/organizing, managing execution, checking results & revising the work plan for complex problems being resolved by cross functional teams. * Basic computer skills including experience in the use of Microsoft word, Excel, etc. * Knowledge of statistical methods. * Strong oral & written communication skills. * Experience with validation test equipment including temperature mapping equipment (for example: Kaye Validator), desired. * Experience with Quality Management Systems (for example: TrackWise, etc.), desired. * Experience in project team collaboration & support. * At least 1 year of demonstrated experience using root-cause analysis techniques to solve problems. #LI-JL1 Job Type: Full-time Salary: $48.00 to $53.00 /hour Experience: * cGMP documentation practices & regulations: 2 years (Preferred) * Change Requests (CR): 2 years (Preferred) * IQ, OQ & PQ protocols: 2 years (Preferred) * Pharmaceutical Validations: 2 years (Preferred) 1 day ago - save job