As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. With a hefty goal of discovering medical breakthroughs to treat devastating neurological ailments, our partner is focused on furthering research and finding ways to improve our healthcare system. You can feel secure in the fact that you will be paving the way to life changing practices when you work for this well-known team! This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.
location: Durham, North Carolina
job type: Contract
salary: $32.48 - 38.22 per hour
work hours: 9 to 5
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
- 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.