Assistant Documentation Specialist

Job Title   Assistant Documentation Specialist    Location   Central Islip or Hauppauge NY locations   Employment Type    Hourly - Full Time    Hourly Range    $20.00-$26.00 Work Hour / Shift    1st shift 7:00 AM - 3:30 PM  Responsibilities/ Accountabilities   Prepare and review Change Controls, Technical Deviations, Methods, Specifications, COAs, Batch Records, Validation protocols/reports. Conduct focused time-studies to support packaging operations.   Support the technical writing and Packaging investigations, Corrective Action Preventive Actions (CAPAs), change controls and validation activities as required.   Apply complete knowledge of process improvement strategies and lean techniques (e.g. Method analysis, work combination charts, ergonomics, visual controls, safety, 5S,Fishbone Diagram,  Kanban, poka yoke) to analyze and improve overall packaging operations.   Participates in the process of crafting and refining ideas, cultivating sources, and developing technical documents.   Perform and direct data mining and analyze the results to provide recommendations or conclusions.   Strict attention to detail and ability to review and edit content for compliance, clarity, and proper use of terminology.   Able to follow documented SOPs for creating documents and storing them   Ability to work independently and collaboratively.   Strong analytical skills with the ability to collect, organize and analyze data so that you may make recommendations and monitor performance.   Performs administrative functions as directed by Management to support projects and to ensure the smooth operation of the department.   Actively participate in Root Cause Analysis to identify areas for improvement including process redesign, workflow alignments and adjustments, and elimination of redundant and unnecessary tasks to create safe, standard, and effective action plans.   Enforce and follow safety regulations and ensure the working area is clean.   Adhere to CIPLA’s Safety, Health, and Environmental policies.   Must be able to work under general supervision and able to work independently and in a team environment.   Must be able to exercise appropriate professional judgment on matters of significance.   Must be willing to work in a pharmaceutical manufacturing setting.   Other duties assigned as required by Manufacturing Management.   Education Qualifications   BA/BS degree in a related field of study from an accredited college/university required.   Experience   One (1) to three (3) years of direct work experience in pharmaceutical manufacturing.  Preference will be given to candidates with experience in generic pharmaceutical manufacturing.   Skills/ Competencies   Advanced Analytical Mathematical Skills.   Ability to communicate the needs and agenda of the packaging department to other groups.   Excellent communications and presentation skills – written and…