
Biotechnology • Pharmaceuticals • Healthcare Insurance
PSC Biotech Corporation is a life science consulting solutions partner that offers a wide range of engineering, technical, and consulting services focused on enhancing operational efficiency, compliance, and quality assurance within the biotech and pharmaceutical sectors. Their expertise includes areas such as auditing, regulatory affairs, commissioning, validation, and project management, helping organizations mitigate risks and streamline processes for successful outcomes in regulated environments.
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Biotechnology • Pharmaceuticals • Healthcare Insurance
PSC Biotech Corporation is a life science consulting solutions partner that offers a wide range of engineering, technical, and consulting services focused on enhancing operational efficiency, compliance, and quality assurance within the biotech and pharmaceutical sectors. Their expertise includes areas such as auditing, regulatory affairs, commissioning, validation, and project management, helping organizations mitigate risks and streamline processes for successful outcomes in regulated environments.
• Create and maintain technical documents for all PSC Software applications that are developed in-house. • These documents include user, administration, API, and quick start manuals for ACE™ and Audit Utopia™ applications. • Support required detail-oriented configuration of the PSC Software™ proprietary, enterprise software. • Configure proof of concept demonstrations to adapt ACE™ to necessary needs. • Support software requirements analysis, customizations, enhancements, integrations, and production deployments of customers/partners. • Works closely and collaboratively with project managers, product managers, operations, and other engineers to ensure high-quality implementation, on-time delivery, and post-implementation technical support. • Interface with internal stakeholders for technical support/sustainment. • Write technical documents including requirements, product customizations, and integration capabilities. • Comply, maintain, and improve the internal quality systems. • Participate in ongoing technical support, training, and service. • Learn to perform critical software documentation with an eye for detail and rigid application of best practices and procedures. • Other duties as assigned.
• Bachelor's Degree in related STEM fields, or equivalent. • At least 2 years of Technical Writing experience related to software specifications and products. • Experience with Technical Writing for cGxP systems or facilities, preferably pharmaceuticals. • Knowledge of FDA Regulations. • Knowledge and experience with Clinical and Regulatory Affairs documentation in a regulated environment. • Excellent verbal and written communication skills. • Strong organizational skills. • Excellent analytical skills. • Ability to work independently in a remote setting. • Must be able to work within U.S Timezone working hours.
• Equal Opportunity Employment Statement • BioTechnique is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment.
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