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- Review GMP raw data for compliance.
- Approve batch-related documentation (Solution Lot records, Reports, Logbooks, Release of Autoclaved Equipment) to support product disposition.
- Transport batch-related documentation across RTP buildings to support chain of custody and life cycle management.
- Support resolution of technical and compliance issues/gaps of mild to moderate complexity.
- Assist Quality Assurance Management in implementing Quality Management Systems required for cGMP compliance and product safety.
- Complete and maintain related GMP training.
- Perform additional job duties as assigned. Experience: 0-2 years directly related to position responsibilities or biologic experience preferred.
qualifications:
- Experience level: Experienced
- Education: Associates
skills: - Quality
- Compliance
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.
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Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
Applications accepted on ongoing basis until filled.
Quality Associate - Research Triangle Park, United States - Randstad USA
Description
job summary:A Quality Associate is needed for a multinational biotechnology company that specializes in the discovery, development, and delivery of therapies for the treatment of neurodegenerative, hematologic, and autoimmune diseases to patients worldwide in the Durham, NC area. The Quality Assurance Associate is responsible for reviewing GMP raw data, approving batch-related documentation, supporting issue resolution, and ensuring compliance with cGMP regulations and company policies.
location: Durham, North Carolina
job type: Contract
salary: $ per hour
work hours: 8am to 4pm
education: Associates
responsibilities: