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Company | Gilead Sciences |
Address | San Dimas, CA, United States |
Employment type | FULL_TIME |
Salary | |
Category | Biotechnology Research,Pharmaceutical Manufacturing |
Expires | 2023-09-18 |
Posted at | 8 months ago |
For Current Gilead Employees And Contractors
- Interfaces with contract manufacturers and suppliers to address documentation and compliance issues.
- Works with operating entities with guidance from senior colleagues to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
- Works with operating entities to develop solutions to more complex problems and identifies deviations from accepted practice and evaluates impact assessment as required.
- Performs a variety of activities to ensure compliance with applicable regulatory requirements.
- Participates in reviews of Standard Operating Procedures (SOPs) to ensure instructions are clear and are consistent with quality objectives.
- Normally receives general instruction on routine work, detailed instructions on new assignments.
- Reviews manufacturing, environmental monitoring and quality control data for in process and finished products with guidance from senior colleagues for investigation support.
- Conducts or serves as lead/coordinator of investigations and corrective action (CAPA) recommendations related to manufactured products.
- Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
- Demonstrates strong verbal, technical writing and interpersonal skills.
- Demonstrates strong knowledge of six sigma, LEAN and root cause analysis tools used for identifying and correcting deviations
- Demonstrates thorough knowledge of FDA / EMEA standards and quality systems, and the interface with other functions like manufacturing, distribution and maintenance.
- Demonstrates proficiency in application of QA principles, concepts, industry practices, and standards.
- Demonstrates proficiency in Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
- Demonstrates proficiency in Microsoft Office applications.
- Demonstrates audit and investigation skills, and report writing skills.
- 4+ years of relevant experience in a GMP environment related field and a BS OR 3+ years of relevant experience and an AA degree.
- Prior experience in pharmaceutical industry is beneficial.
- Must have strong writing skills to present findings in a clear and concise manner.
- QA experience preferred. Educational background in the sciences (Engineering, Biology, Chemistry).
- Must have a desire to demonstrate excellence by setting high standards
- Must be detail-oriented and able to demonstrate a high standard of integrity.
- Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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