Civica Senior QA Operations Lead
1 week ago
Job Summary:
We are seeking an experienced Civica Senior QA Operations Lead to join our team.
About the Role:
This is a unique opportunity to lead our Quality Assurance Operations department and ensure that they are qualified, achieve a high level of competence, and carry out their duties in a safe manner.
Main Responsibilities:
- Maintain current knowledge of regulatory and legislative requirements and trends to ensure expert advice and appropriate technical support on all quality-related matters.
- Ensure procedural documents, manufacturing batch records, and processes within the manufacturing operations are in accordance with FDA regulations and GMPs.
- Responsible for approving raw materials, excipients, APIs, and components material qualifications.
- Responsible for ensuring that all components, raw materials, excipients, drug product containers, closures, in-process materials, packaging material, labeling, and drug products are released in accordance with the registered specifications.
- Support quality processes and systems across the product lifecycle, including change control, CAPA, deviations, and investigations.
- Participate or lead in quality risk analysis process transfers.
- Proactively identify and work collaboratively to resolve problems taking risk-based and compliant approaches to solutions.
Requirements:
- 8+ years experience working directly with manufacturing in the sterile injectable pharmaceutical and packaging operations.
- Bachelor-level or higher education.
- Project management, organization, and execution skills are required.
- Ability to apply technical expertise to solve problems and issues.
Preferred Qualifications:
- Experience in Drug Enforcement Agency requirements for the handling and distribution of controlled substances is desired.
- Experience with isolator technology.
About Civica:
We are a leading company in the industry, committed to delivering high-quality results and working with others to overcome challenges.
Salary: $120,000 - $150,000 per year.
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