Technical Writer with Pharma exp

TSR is a premier National U.S. Staffing company with over 50 years of staffing excellence.Our client, a leading pharmaceutical company is hiring a Technical Writer. Please ONLY local candidates to Warren NJ.Bachelors degree required. Strong understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry is a MUST. MUST have strong technical writing skills and the ability to execute validations in an aseptic environment.Work ***** Warren NJ***** $50-51/hour W2Supports the successful implementation of laboratory equipment and systems at multi-use sites through interaction with internal customers and external service providersThe incumbent in this role, contributes to the completion of milestones associated with facility, utility, and equipment qualificationMust have excellent technical writing skills and proficiency with Microsoft Word formatting functions; ability to efficiently create technically accurate documents for system lifecycle deliverables in alignment with the site validation program; highly attentive to spelling, grammar, punctuation, and overall document qualityExperience writing Standard Operating Procedures, Work Instructions/Practices, and Risk Assessments for pharmaceutical production processes and/or manufacturing equipment, systems, utilities, and facilitiesExperience authoring and executing commissioning/qualification/validation deliverables including plans, system requirements, protocols, traceability matrices, and summary reportsExperience writing protocol deviations, investigating out of specification results, performing corrective and preventive actions, and executing change controlsStrong computer skills in Microsoft Office Suite - Word, Excel, Outlook and Teams, and the ability to learn new software as requiredPreferred experience with Blue Mountain Regulatory Asset Manager and Veeva Vault applicationsAuthor and execute commissioning/qualification/validation deliverables including assessments, plans, system requirements, protocols, traceability matrices, and summary reports for manufacturing equipment, systems, utilities, and facilitiesAuthor protocol deviations, investigate out of specification results, perform corrective and preventive actions, and execute change controlsDevelop written procedures for operation, cleaning, and maintenance of equipment and systems

Created: 2024-11-01