Validation Specialist in Albany, NY at Johnson Service Group

Date Posted: 10/21/2019

Job Snapshot

Job Description

JobID: 375474

A validation and quality assurance provider are looking to for Validation Specialists with 5+ years’ experience for their Albany, NY project site. This unique group works to develop and blueprint a universally implemented validation process that reliably achieves quality, affordable and available healthcare products.

This assignment is a 6-month temp to direct position.

Rate: $45-50/hour. 

Responsible for Laboratory Instrument/Equipment Qualification remediation for the following equipment: Refrigerators, Incubators, Ovens, In-Vitro Baths. Responsible to generate IQ, IQ Reports, OQ, OQ Reports, PQ and PQ Reports, operational procedures and protocol deviations.
• Responsible to develop protocol templates and qualification strategies based on the intent of use of the equipment and instruments.
• Coordinated between supporting areas to assure the success of the validation activities and timelines.
• Performed 21 CFR part 11 assessments, User access control reviews, data integrity and training personnel on GMP and GDP related aspects.
• Handled process equipment such as fluidized Bed dryer, Autoclaves, Heat Exchangers, Mixers, Tray dryer, High Shear Granulators, Bin Blender, Control system
• Prepared, reviewed and approved validation protocols for Manufacturing/Packaging (Fluid Bed Dryers, Filler machines, Tablet Press Machines, Autoclaves and V- Blenders) and laboratory (FTIR, HPLC and TOC) systems.
• Responsible for CSV qualification activities for HPLC's, GC's and UV's. Implementation of Chemstation
• Authored validation documents such as IOQ for the qualification of new replacing HPLC columns
• Executed Operational Qualifications (OQs) to make sure that the columns are capable of consistently operating between established limits and tolerances.
• Prepared documents for computer systems validation, reports on IQ, OQ and PQ protocols in accordance to FDA standards
• Evaluated and Generated DCR (Document Change Request) & DCO (Document Change Order)
• Reviewed, analyzed and approved test scripts through automated HPQC for ERP in Sales and Distribution module, instrument systems such as GC, LC, FTIRs, and Mass Spectrometer
• Developed Validation Protocols, Summary reports for Validating QC laboratory equipment.
• Extensively used Electronic data management system (EDMS) for storage, retrieval and tracking versions of all the Validation documents for the different processes and equipment.
• Executed the formula design of experiments (DOE) for a new deodorant stick development using Minitab Software and worked on product and process development.

JSG is a leading staffing agency specializing in a variety of industries. Having been named to three Staffing Industry Analysts (SIA) lists for the third year in a row, JSG continues to grow and offer hiring solutions to companies across the United States.  JSG serves both busy recruiters and qualified candidates within multiple industries from our major offices headquartered in Chicago and Atlanta with local offices throughout the United States and Canada.

Please email resume to Allen Mudalel