Jobs · Writing · Indiana

Deviation Writer - Tech Services

INCOG BioPharma Services · Fishers, IN · 1 wk ago
On-siteWritingFull-time

INCOG BioPharma Services is seeking a Deviation Writer for our Tech Services department. Please apply through the provided link.

About the role

The Deviation Writer is responsible for documenting and reporting deviations from established procedures in a clear and concise manner. This individual will work closely with cross-functional teams to ensure that all deviations are thoroughly investigated and corrective actions are implemented.

Responsibilities

  • Document deviations in accordance with company policies and regulatory requirements
  • Work with cross-functional teams to investigate deviations and develop corrective action plans
  • Prepare and submit deviation reports to appropriate stakeholders
  • Ensure adherence to Good Documentation Practices (GDP)
  • Participate in training sessions on deviation management

Requirements

  • Bachelor's degree in a relevant field (e.g., Quality Assurance, Biotechnology, Pharmaceutical Sciences)
  • Minimum 2 years of experience in a pharmaceutical or biotech environment
  • Strong knowledge of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP)
  • Excellent written and verbal communication skills
  • Proficiency in Microsoft Office Suite

Qualifications

  • Experience with regulatory compliance and documentation
  • Knowledge of industry standards and best practices in deviation management
  • Ability to work independently and as part of a team

Skills

  • Strong analytical and problem-solving skills
  • Attention to detail and accuracy in documentation
  • Effective time management and organizational skills

Benefits

  • Competitive salary package
  • Flexible working hours
  • Professional development opportunities
  • Health insurance benefits
  • Employee assistance program

Pay

Commensurate with experience

Schedule

Full-time, Monday through Friday

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