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 5SFishbone 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 CIPLAs 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 verbal; fluent in English.

• Strong knowledge in all Microsoft office computer applications (i.e. Word Excel PowerPoint etc.) and pdf to create edit draft and control.

• Good understanding in cGMP current technologies and current FDA guidelines.

• Able to prioritize plan and work under tight schedules and deadlines.

• Must possess strong documentation and technical writing skills and be able to apply relevant scientific principles and practices.

• Must communicate clearly and concisely across levels both orally and in written.

• Strong command over written and verbal English is required.