harbaheadercoverblack.png

Technical Writer

Fishers $70,000 - $85,000 Permanent

Job Responsibilities:

  • Utilize advanced technical writing methods to produce documentation that is clear, concise, and thorough.
  • Create and maintain technical documents including Standard Operating Procedures (SOPs) for facilities and equipment, batch records, specifications, and training materials.
  • Lead and oversee change controls to implement new procedures and update existing documentation and SOPs for product launches.
  • Participate in process and equipment testing to gain a comprehensive understanding of the systems being documented.
  • Manage deviations, Corrective and Preventive Actions (CAPAs), change controls, document updates, and training assignments to adhere to quality system standards and deadlines.
  • Collaborate with operations, R&D, and quality teams to fulfill all documentation requirements for projects.
  • Ensure compliance with US and international regulatory standards and guidelines (e.g., FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP).


Qualifications:

  • Bachelor’s degree or equivalent professional experience.
  • At least 3 years of relevant experience.
  • Excellent English communication skills, including proficiency in grammar and composition.
  • Deep understanding of GMP/cGMP regulations.
  • Exceptional written and verbal communication abilities, with experience working in cross-functional teams.
  • Strong time management skills and meticulous attention to detail.
  • Proven capacity to manage multiple projects in a dynamic, professional environment.
  • Ability to work independently as well as part of a team.
  • Competent in reading, understanding, and following work instructions accurately and safely.
  • Skilled in Microsoft Word, PowerPoint, and Excel.
Share this job:

Apply now

Similar Jobs

Production Technician

Plainfield $17 - $20/HR Contract

Job Description: Perform hands-on assembly, labeling, and packaging of diagnostic or sample collection kits according to detailed SOPs Prepare...

Analytical Laboratory Manager

Indianapolis $75,000 - $90,000 Permanent

Responsibilities Oversee daily operations of the analytical laboratory, including staff supervision, workflow management, and equipment oversigh...

Medical Assistant

Greater Boston $25 - $30/HR Contract

Responsibilities: Take patient medical histories and prepare them for examination. Assist with medical procedures and exams under the directio...

Laboratory Specialist

Indianapolis $20 - $22/HR Contract

Job Responsibilities Perform sample preparation activities, including aliquots, DNA/RNA purification, and quantification. Follow client-specif...

Specimen Processor

Indianapolis $16 - $17/HR Contract

Job Responsibilities: Receive, log, and accession incoming specimens according to established procedures. Verify the accuracy of specimen info...