Quality Assurance Specialist
1 week ago
Clinical Quality Assurance Representative at Global Channel Management Inc.
We are seeking a highly skilled Clinical Quality Assurance Representative to join our team. The ideal candidate will have a strong background in GMP pharmaceuticals and 2+ years of experience in a similar role.
Key Responsibilities:
- Perform incoming sample inspection for batch release and ensure product packaging and labeling compliance.
- Provide oversight for sample management to ensure compliance for the handling of Special Security Substances (SSS) and controlled substances.
- Obtain authorization to handle Controlled Substances (CS).
- Provide consultation and interpretation of local procedures, corporate standards, and regulatory expectations that apply to sample management.
- Serve as the QA Data Steward for reserve sample lots created in SAP.
Requirements:
- Strong knowledge of cGMPs, Quality Systems, and FDA Regulations.
- Bachelor's degree in a science-related field and/or relevant experience in a pharmaceutical GMP environment.
- Ability to work across functional areas with people of all levels of the organization.
- Strong oral and written communication skills.
- Demonstrated interpersonal and networking skills.
- Ability to gather, edit, organize, and summarize information from multiple sources.
- Must exhibit attention to detail.
- Ability to work under time pressure with proven demonstration of good judgment in making decisions under minimum supervision.
- Excellent teamwork and interpersonal skills.
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