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