Technical Writer

Operations Seymour, Indiana


Description

JOB SUMMARY:    

This position is primarily responsible for writing protocols and reports in support or laboratory investigations, along with other miscellaneous technical writing responsibilities such as statistical design and analysis of laboratory results.

ESSENTIAL DUTIES / RESPONSIBILITIES:

  • Assist in the effective and timely investigation of atypical lab data results including the determination of root causes and writing the necessary protocols and reports.
  • Create, review and/or provide input in annual product review reports.
  • Evaluate equivalency of data sets such as for method transfers, alternate methods, raw material certification, and stability evaluations of alternate configurations.
  • Work with analysts and/or management in writing and revising lab Standard Operating Procedures (SOP).
  • Assist in special projects or other tasks as deemed necessary based on individual’s qualifications, business needs and laboratory operations management’s discretion.

 REQUIRED EDUCATION:

     
    Bachelor’s Degree – Chemistry, Mathematics, or related field

QUALIFICATIONS/EXPERIENCE:  

  • At least 5 years of pharmaceutical testing experience in a cGMP-regulated laboratory environment.
  • Pharmaceutical industry statistical experience preferred.
  • Knowledge of cGMP, USP/NF, ICH, EU and FDA guidelines and regulations.
  • Expertise in Microsoft Word and Excel. Experience with Stability System Software and SAS preferred.
  • Demonstrated ability to work as part of a cross-functional team.

 SPECIFIC SKILLS:

  • Excellent oral communication skills and technical writing skills.
  • Well organized, detail-oriented, and dependable.
  • Able to assist with troubleshooting analytical methods and lab instrumentation (e.g. HPLC, GC, dissolution, wet chemistry).