Operations Technical Writer

  • Torrent Pharma Inc.
  • Levittown, PA, USA
  • Aug 09, 2021
Full time Engineering

Job Description

Summary:

The major responsibility of the Operations Technical Writer is to write, review, revise and maintain technical documents within the Production and Engineering departments. The Technical documents include, but are not limited to Manufacturing and Packaging Master Production Records, Production and Engineering Deviations, Events, Investigations and Standard Operating Procedures related to the position. The Operations Technical Writer will report to the Site Head and efficiently conduct all duties and responsibilities assigned, and/or delegated by the Site Head.    

Essential Duties and Responsibilities:

  • Responsibilities include the following but are not limited to:
  • Write, review and revise the following documents in support of Production and Engineering
  • Manufacturing and Packaging Master Records
  • Events
  • Deviations
  • Investigations
  • Relevant SOP’s
  • Reviews and revises documents prepared by others and coordinates the preparation of those materials for completed documents
  • Reviews and edits complex written technical materials for accuracy, clarity, and completeness
  • Address comments from SMEs and different stake holders to finalize/approve the documents, and follows up for their approval process in a timely manner to meet the targeted timelines
  • Ensure investigations adhere to compliance-driven timelines and are compliant with cGMP regulations
  • Demonstrates the ability to prioritize conflicting demands
  • Executes assigned tasks within established timelines
  • Complies with company policies, procedures, rules and regulations
  • Maintains confidently and communicates effectively

 ADDITIONAL RESPONSIBILITIES:

  • May require technical review of previously generated data for regulatory responses
  • Maintains and demonstrates a high level of personal and professional integrity
  • Reports any suspicious activity to management

  

QUALIFICATIONS:

To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed represent the knowledge, skills, and ability required for this role.

 Safety Requirements:

  • Ensure adherence to all personal protective equipment
  • Report facility, department and/or any other observed safety related concerns immediately to Manager and/or Human Resources

Competencies/Skills:  

  • Proficiency in Microsoft Office particularly in Excel, PowerPoint and Word
  • Proficient in technical writing
  • Ability to learn quickly, perform multiple tasks simultaneously, keep accurate record, follow instructions and comply with company policies
  • Ability to work independently and as part of team, self-motivation, adaptability and positive attitude
  • Must be able to work in a cross-functional environment interacting with other internal departments and external vendors
  • Must be able to communicate technical, scientific, and regulatory information, both written and verbally
  • Ability to work in a detail-oriented manner
  • Ability to meet attendance standards: All full-time employees are required to work a 40-hour week. At times it may be necessary to work additional hours in order to accomplish the required tasks to meet deadlines.

 Education and Experience:

  • Bachelor’s degree or higher in Science Field, Engineering, Pharmacy preferred
  • Three or more years of demonstrated excellence in the field
  • Three or more years of experience in writing technical documents
  • Knowledge of cGMP and related compliance regulation and guidance is required

               

Language Skills:                                                             

  • Ability to read and comprehend instructions in the English language through verbal and written methods.
  • Ability to write or speak in the English language and communicate information effectively in one-on-one and groups within the organization.

 

Reasoning Ability:                                                        

  • Ability to apply common sense understanding to carry out multi-step instructions
  • Ability to deal with standardized situations including occasional variables

 

Physical Demands: Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Required to stand and walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl, and talk or hear

 

Work Environment:

  • Noise level in the work environment is usually moderate but may be loud at times