United Pharma · 1 day ago
Quality Assurance Engineer
North Carolina, United States
Contract
Onsite
Senior Level
5+ years expUnited Pharma is seeking an experienced Parenteral Deviation Investigator to support a newly launched aseptic prefilled syringe manufacturing line during early commercial production. This high-impact role involves leading deviation investigations and ensuring compliance with GMP standards.
Staffing & Recruiting
Hiring Manager
Chandra Sekhar.s
Responsibilities
Own and manage deviation investigations for an aseptic prefilled syringe manufacturing line
Conduct thorough root cause analyses and document investigations within Veeva QMS
Author clear, technically robust deviation reports and support the development and execution of CAPAs
Collaborate closely with Manufacturing, Quality, Engineering, and MSAT teams
Support line stabilization efforts during startup and early commercial operations
Identify, trend, and communicate investigation insights to drive continuous improvement
Ensure all activities comply with GMP regulations and site quality requirements
Qualification
Required
Minimum of 5 years of experience as a Deviation Investigator in a GMP-regulated environment
Hands-on experience supporting parenteral and/or aseptic manufacturing operations
Strong working knowledge of Veeva QMS
Proficiency with root cause analysis methodologies (e.g., 5 Whys, Fishbone)
Excellent technical writing and documentation skills
Preferred
Experience supporting new manufacturing line startups or early commercial production
Ability to perform effectively in high-visibility, rapidly changing manufacturing environments
Company
United Pharma
United Pharma Solutions is a professional company dedicated to business development in the pharmaceutical industry.
11-50 employees
H1B Sponsorship
United Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (50)
2024 (81)
2023 (77)
2022 (69)
2021 (46)
2020 (57)
Funding
Current Stage
Early StageCompany data provided by crunchbase