Job Title: Sr. Specialist, Deviations & Investigations

*No C2C/No Sponsorship at any point*

Location: Norwood, MA

Duration: 6+ month contract

Pay: $90.00 per hour

Position Overview:

The Quality Control Technical Writer will develop, revise, and maintain key QC documents such as SOPs, test methods, and specifications. The role involves leading investigations for CAPA, deviations, and OOS events, performing lab support activities, and documenting findings. The position requires strong technical writing skills, laboratory expertise, and the ability to collaborate with cross-functional teams to address quality issues.

Key Responsibilities:

• Write and revise SOPs, specifications, and test methods.
• Lead and document CAPA, deviation, and OOS investigations.
• Conduct laboratory support tasks and assess methods and data.
• Facilitate meetings and support QC teams on quality control issues.
• Ensure compliance with regulatory standards and QMS tools (e.g., Veeva, TrackWise).

Required Qualifications:

• BS in Life Sciences, Chemistry, or related field.
• 8-10 years of experience in QC or laboratory-based roles with strong technical writing skills.
• Experience in CAPA, deviation, and OOS investigations.
• Proficiency with QMS tools (e.g., Veeva, TrackWise) and LIMS.
• Strong communication skills for writing and running meetings.

Nice to Have:

• Experience with Fishbone analysis.
• Familiarity with FDA/GMP regulations.