inSync Staffing
Quality Assurance
inSync Staffing, Elkhart, Indiana, United States, 46516
Quality AssurancePay Rate : $33.65/hr, paid weekly.Hours : 8:00 a.m. - 5:00 p.m., Monday - Friday.Location : Onsite in Elkhart, IN 46516.Duration : 1 year.SummaryThe role focuses on document control, record review, and equipment management for a manufacturing group producing in-vitro diagnostic components.
Requirements
Bachelor's in Life Science or relevant experience.Experience in GMP/ISO regulated environments is preferred.Familiarity with Good Documentation Practices (GDP).Attention to detail and professionalism.Key Responsibilities
Manage document control systems, including review and changes.Archive quality records.Conduct detailed reviews of device history records (DHRs).Manage batch disposition in SAP.Track metrics for batch records and document control.Review equipment service records and update electronic management systems.Validate and ensure completion of records in line with GDP.Assist with additional Quality Assurance tasks.Preferred Skills (Not Required)
Experience with 21 CFR 820 or ISO 13485.Equipment validation and service management.Technical writing and SAP Quality Management experience.Benefits
(employee contribution)
Health, dental, and vision insurance.Health savings and flexible spending accounts.Life insurance and retirement plan.
All qualified applicants will be considered regardless of age, race, color, religion, gender, sexual orientation, disability, or veteran status.
#IND09
Requirements
Bachelor's in Life Science or relevant experience.Experience in GMP/ISO regulated environments is preferred.Familiarity with Good Documentation Practices (GDP).Attention to detail and professionalism.Key Responsibilities
Manage document control systems, including review and changes.Archive quality records.Conduct detailed reviews of device history records (DHRs).Manage batch disposition in SAP.Track metrics for batch records and document control.Review equipment service records and update electronic management systems.Validate and ensure completion of records in line with GDP.Assist with additional Quality Assurance tasks.Preferred Skills (Not Required)
Experience with 21 CFR 820 or ISO 13485.Equipment validation and service management.Technical writing and SAP Quality Management experience.Benefits
(employee contribution)
Health, dental, and vision insurance.Health savings and flexible spending accounts.Life insurance and retirement plan.
All qualified applicants will be considered regardless of age, race, color, religion, gender, sexual orientation, disability, or veteran status.
#IND09