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location: Durham, North Carolina
job type: Contract
salary: $32.48 - 38.22 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
The Senior Quality Assurance Associate is responsible for contributing to the oversight of key strategic, tactical, and operational aspects within Quality Assurance. Activities include, but are not limited to: review of GMP raw data for compliance, review of GMP documentation to support batch disposition, review/approval of GMP procedures, protocols and reports, GxP Quality systems-related training, identify gaps in existing Quality systems and propose solutions to site management.
- Review and approval of batch related documentation (cGMP procedures, Master Production Records, Solution Lot records, protocols and reports) to support product disposition
- Review of executed Batch Records, procedures, forms, master production records
- Review and approval of Investigations
- Executes activities including; intermediate technical writing, intermediate investigation support (root cause analysis/impact assessment), project representation (moderate complexity)
- Supports resolution of both technical and compliance issues/gaps of moderate complexity. Aides in implementation of Quality Systems/System Improvements with some guidance, moderate technical problem solving (tools or enterprise systems) within function and across multiple functional areas
- Assists Quality Assurance Management in additional responsibilities related to the day-to-day implementation of the Quality Management Systems required to maintain cGMP compliance, and ensure the safety, efficacy and purity of the products manufactured by the company
- Control and release of equipment from maintenance, validation, change control and product changeover
- Supports and/or assists in GxP quality systems-related training. Provides some mentorship and training within and across functions
qualifications:
- Quality and Compliance experience (CFR, ICH, ISO, etc.)
- Biologics experience (Cell Culture and Purification Manufacturing experience)
- Experience with Trackwise and/or ORACLE/SAP
skills: Quality Assurance, Protein Purification, Cell Cultures, ICH Regulations, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.