- Experience
- 3–10 yrs
- Salary
- —
- Openings
- 1
- Posted
- 3 days ago
- Work mode
- In office
- Education
- Bachelor’s degree in a scientific field
- Eligibility
- Candidates with a scientific bachelor’s degree and the required GMP quality assurance / QMS experience may apply.
- Resume
- Required to apply
Where you'll work
Job description
Job summary
ALOIS Solutions is hiring a Quality Assurance Analyst in Durham, NC for an onsite contract assignment. The role sits within the GMP Quality Assurance function and reports to the Manager, GMP Quality Assurance, or another designated leader. The position supports the organization’s Quality Management System (QMS) and helps reinforce a strong culture of quality across the business.
This position is focused on maintaining compliance with applicable GMP requirements across national, international, and state-level regulations.
Key responsibilities
- Handle assigned daily QA tasks that keep the company’s Quality Management System running smoothly.
- Support requests related to the Learning Management System, Change Control, Deviation Management, and other QMS-driven processes in a prompt manner.
- Prepare and share weekly and quarterly QMS metrics and KPI updates for QA and CMC senior leadership.
- Work closely with cross-functional teams to ensure direct and support activities are completed on schedule.
- Represent the Quality Unit in project meetings and serve as a knowledgeable resource on quality and compliance matters.
- Help drive continuous improvement efforts and provide oversight for QMS-related activities.
- Assist with regulatory and internal audits or inspections in line with company procedures and relevant requirements from agencies such as FDA and EMA.
- Keep stakeholders informed about project progress and raise issues early when needed.
- Take on additional quality-related duties as assigned by management.
Candidate profile
The ideal candidate holds a bachelor’s degree in a scientific discipline and brings either 4 or more years of GMP Quality Assurance experience supporting or overseeing a company QMS, or 10 or more years of GMP-based QA experience using a company QMS.
At least 3 years of hands-on experience with a pharmaceutical or biotech Quality Management System such as Trackwise, ZenQMS, or Veeva is required. A strong working knowledge of GMP guidelines and quality systems is essential, along with the ability to apply GMP standards in line with U.S. expectations and, where relevant, other regulatory authorities.
Experience writing, reviewing, and interpreting SOPs is needed. Background in analytical method validation and QC testing is preferred, especially in mammalian cell culture and gene therapy/biologics potency testing. Proficiency with Microsoft Word, Excel, and PowerPoint is also expected.
Additional information
The role is based in Durham, NC and requires onsite presence. No salary or stipend details were provided in the source.
Work type
This is a contract position.