Technical Writer

3 weeks ago

Pleasant Prairie, United States Medasource Full time

Technical Writer, MQA (Manufacturing Quality Assurance)

First Shift

Pleasant Prairie, WI

Responsibilities:

  • Provide support for Parenteral Operations by researching, organizing, writing, editing, and formatting technical information to produce high-quality documents.

Key Objectives / Deliverables:

  • Creating and revising standard operating procedures, work instructions, forms, and other controlled documents to communicate complex technical information in a clear and concise manner.
  • Perform gap assessments between global and local procedures to identify areas that require remediation or continuous improvement.
  • Utilize completed gap assessments to revise or create controlled documents.
  • Collaborating with subject matter experts and technical staff to create or revise controlled documentation.
  • Ensuring that the written content meets the needs of its intended audience.
  • Responsible for the timely closure of assigned quality records.
  • Serve as document administrator within the electronic Quality Management System (eQMS), MasterControl.
  • Process document changes and management of changes while ensuring good documentation practices (GDP) within the eQMS, MasterControl, and compliance to Nexus Pharmaceutical’s procedures.
  • Perform initial change control requests for proper workflow and change control documentation requirements within MasterControl.
  • Act as contact person for troubleshooting record workflow through MasterControl change control process.
  • Perform document control review following area manager and QA approval to ensure proper formatting.
  • Launch new documents within MasterControl to assist with document change control lifecycles.
  • Manage and ensure compliance to record retention policy.
  • Schedule and track the periodic review of controlled documents.
  • Maintain and issue logbooks to Operations, Engineering, Micro/QC Laboratories as needed.
  • Maintain, issue, and reconcile serialized forms.
  • Other duties as assigned.

Basic Requirements:

  • Education
  • 4-year bachelor’s degree in science-related strongly preferred. (Additional GMP Quality Experience may be accepted in lieu of degree)Experience
  • Experience
  • 3+ years of relevant experience. Pharmaceutical preferred.
  • Knowledge of Microsoft Office Suite Programs required.
  • Familiarity with digital QMS systems, MasterControl preferred.

Additional Skills/Preferences:

  • Specific skill set: quality minded, critical thinking, technical writing, problem solving, experience in investigative techniques, highly detail oriented, and highly organized
  • Ability to communicate clearly and concisely when conveying information, summarizing facts, asking questions, etc.
  • Must be able to work independently
  • Strong organizational skills

Physical Requirements:

Lifting requirements less than 50 pounds

Sitting 85% of day

Office , Manufacturing, and Laboratory Environment

Other Information:

  • Ability to work 8 hour days – Monday through Friday
  • Ability to work overtime as required.

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

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