Validation Specialist II

Artech is a global staffing and IT consulting company. We are constantly on the lookout for professionals to fulfill the staffing needs of our clients, and we currently have a job opening that may interest you. Below is a summary of the position. Job Title: Validation Specialist II Location: Swiftwater, PA 18370 Duration: 07-12 Months Duties: Background: The position is responsible for providing MTech Project Leaders with assistance in the management of samples collected and tested in support of studies for projects, non-commercial stability programs, manufacturing assistance, or investigations. Scope of work: - Typical scope of work required to support Pharmaceutical Technology department: - Submit/approve Quality Control Independent Demand (QCID) for testing required for study. Manage SAP and LIMS to ensure Operations has the testing containers and documentation - Monitor sample delivery and testing labs to ensure all samples are tested and results reported - Manage LIMS approval process concurrent with Batch Record and MS approval Deliverables: - Ongoing deliverables in performance of this function. - Approved QCID form - Logistics for collections, movement, and chain of custody - Sample delivery within current written instructions and guidelines - Communication and delivery of sample results to support project team needs, commercial needs, and requirements for cGMP batch disposition. Expectations: - The background for this position is experience with company policies and applications. - The expected capabilities for individuals receiving a contract to support this scope of work are as follows: - Strong background in Microsoft Excel, MS Word, SAP, Labware, Batch Records, Operational SWIs, Governing site SOPs, Product Specifications, Documentum, and Trackwise. - Strong communication and networking skills capable of delivery of information at all levels of the organization. Strong written skills. - Successful completion of Training Module TMVALEXT007-001 Skills: - MS Office with emphasis on Excel and Word - E Doc - Labware - Trackwise - 3-5 years working in a cGMP environment Education: - BS/BA in Life sciences or Associates with 5-7 years’ experience Refer Job Description URGENT REQUIREMENT ! ! ! SWIFT ACTION FROM CLIENT EXPECTED