Select Source International · 15 hours ago
Quality Assurance Documentation Specialist
Des Plaines, IL
Contract
Onsite
Senior Level
5+ years expSelect Source International is a company focused on ensuring high product quality through effective collaboration. They are seeking a Quality Assurance Documentation Specialist responsible for reviewing qualification and validation documents and supporting the qualification and validation processes for manufacturing expansions.
ConsultingFinancial ServicesInformation Technology
Responsibilities
Works with a cross functional team to review qualification and validation documents which meet company and regulatory requirements
Supports the complete qualification and validation process to implement new manufacturing FUE and automation, process, test method validations in support of a manufacturing expansion
Especially in HPLC synthesis, purification, and testing. Supports on-market change control projects
Qualification
Required
Bachelor's degree in Life Science; Engineering; or closely related discipline is required OR relevant combination of education or experience
At least 5 years work experience in Quality or related field experience; Has a history of completing successful projects and driving positive compliance outcomes
Preferred
Bachelor's or master's degree in one of the following Engineering disciplines: Chemical, Electrical, Bio-medical, or Mechanical
5+ years of relative professional work experience in Medical Device Quality/Pharmaceutical or in a regulated industry
Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971
Strong technical writing skills; Polished verbal and written communication skills
Company
Select Source International
Select Source International (SSI) is an award-winning global leader in Consulting and Staff Augmentation, helping businesses thrive across IT, Healthcare, Finance & Accounting, Human Resources, Engineering, Energy & Utilities, Manufacturing, Administrative, Operations & Logistics, and more.
501-1000 employees
H1B Sponsorship
Select Source International 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 (2)
2024 (2)
2023 (3)
2022 (2)
2020 (4)
Funding
Current Stage
Late StageCompany data provided by crunchbase