Deviation Investigation Support
For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle.
About the role
This is a 15-month contract position, beginning in Q4 2026 through the end of Q4 2027. The deviation writers will be involved in meetings with site representatives for deviation events, collaborating with subject-matter experts (SMEs) as needed, and providing deviation investigation support with updates as required.
Deviation writers will complete training with the company and be responsible for:
- Completion of training on time
- Presence and engagement at meetings
- Clear communication of progress on deviation records
- Ownership of deviation records through approval, including but not limited to:
- Thorough root cause investigation, including process background, event overview, creation of CAPA(s), and effectiveness checks
- Set-up of deviation review board when applicable
- Routing deviation records for review and approval
Requirements
- Background in Quality Control Laboratories
- Experience in root cause investigation and CAPA creation
- Excellent communication, technical writing, and time management skills to ensure timely and high-quality deviation writing and approval
- 5+ years of relevant experience
Skills
- Experience with systems such as Veeva QMS, MODA, and SmartLab (helpful)
- LabVantage experience (a plus)
Schedule
This is a 15-month contract role, running from Q4 2026 through the end of Q4 2027.