Specialist, Technical Writing

Holly Springs, North Carolina

Job Title: Specialist, Technical Writing

Location: Hybrid (up to 60% onsite)

Are you an experienced technical writer with a strong background in the pharmaceutical industry? Our client is seeking a Specialist in Technical Writing for their Quality Control (QC) Laboratory. This role requires a minimum of 8-10 years of experience and a deep understanding of GMP/regulatory requirements within a QC laboratory setting.

Job Responsibilities:

  • Independently create robust, technically sound Standard Operating Procedures (SOPs), Operation and Maintenance (O&M) Procedures, and Equipment Data Integrity Assessments for QC Laboratory Startup
  • Manage document changes within the electronic Quality Management System (eQMS) while adhering to good documentation practices (GDP)
  • Oversee document lifecycle updates to support QC Laboratory Readiness metric reporting
  • Author Analytical Equipment Qualification Protocols and Compendial Verifications
  • Maintain a strong focus on GMP Quality Control within the Pharmaceutical Industry

Skills Required:

  • Minimum 8 years’ experience performing analytical testing
  • Master’s degree in Analytical Chemistry, Physical or Pharmaceutical or Life Sciences, or Engineering-related discipline preferred
  • Proficiency in small molecule/peptide analysis in support of process development/scale-up activities and formulation development in GMP and non-GMP environments
  • Experience with a variety of chromatographic and spectroscopic techniques
  • Ability to work independently and produce quality results with minimal direction
  • High energy, ability to multi-task, and thrive in a fast-paced, dynamic work environment

About SSi People: 
With over 25 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.

 

 

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