Deviation Investigation Support

ProPharma • Raleigh, NC

1d • Hybrid

About The Position

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. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

This will be a 15-month contract, beginning in Q4 2026 through the end Q4 2027.

The deviation writers will be involved in meetings with site representatives for deviation events, collaborating with SMEs as needed, and providing deviation investigation support with updates as needed.

The deviation writers will go through 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 the following activities:
Thorough root cause investigation, including process background, event overview, creation of CAPA(s) and effectiveness checks.
Set-up deviation review board when applicable
Route deviation records for review and approval

Requirements

• Background in Quality Control Laboratories
• Experience in root cause investigation
• CAPA creation
• Excellent communication skills
• Excellent technical writing skills
• Excellent time management skills
• 5+ years of relevant experience

Nice To Haves

• Experience with systems such as Veeva QMS, MODA, and SmartLab
• LabVantage experience

Responsibilities

• Completion of training on time
• Presence and engagement at meetings
• Clear communication of progress on deviation records
• Ownership of deviation records through approval
• Thorough root cause investigation, including process background, event overview, creation of CAPA(s) and effectiveness checks.
• Set-up deviation review board when applicable
• Route deviation records for review and approval

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed