Technical Services Associate

7 days ago

Hartford, Connecticut, United States KVK Tech Full time
Job Description

Job Summary

We are seeking a highly skilled Technical Services Associate to join our team at KVK Tech. This individual will provide technical and proposal writing support to the Technical Services division, assist with development and delivery of process records for production, and execute all functions in accordance with current FDA regulations, ICH guidelines, USP methodologies, cGMPs and SOPs.

Key Responsibilities

  • Develop, write and review technical documentation, including manufacturing and packaging batch records.
  • Manage the review, tracking, GMP compliance and approval of Change Controls for Production Processes, Facilities and Equipment.
  • Develop, write and review/updates SOPs.
  • Prepare various summary forms for Pharmaceutics related projects, as well as graphs, charts and statistical analysis for establishing product specifications.
  • Design, develop and implement databases to track key project deliverables and resource allocation within Pharmaceutics.
  • Provide investigation expertise and technical writing expertise to perform and document process Deviations and Events.
  • Implement Change Control management in production and engineering.
  • Review and approve documentation associated with cGMP Compliance. Assess and document product quality impact.
  • Assist regulatory to provide technical documentation for submission.
  • Assists with the development of departmental project timelines and project plans.

Requirements

  • Bachelor's degree in chemical engineering preferred.
  • 1-3 years of experience in a related field.
  • Strong technical competencies, including preparation and approval of SOPs, quality improvement initiatives, and statistical analysis.
  • Excellent written and oral communication skills.
  • Ability to act independently and work in a team environment.

Work Environment

This position requires the ability to walk, sit, and use hands to finger, handle or feel tools or controls, reach with hands and arms, balance, stoop, crouch, bend, talk and hear. The employee must lift and/or move up to 20 pounds.

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