Quality Assurance Manager
1 day ago
Civica is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. Our mission is to ensure the consistent availability of affordable medications, particularly for those who are uninsured or underinsured.
Job DescriptionThe Quality Assurance (QA) Operations Manager will play a critical role in ensuring the Petersburg site's manufacturing and operations activities comply with applicable regulatory standards. This includes managing relationships with external partners, leading quality assurance processes, and driving product and process changes to improve product quality.
Key Responsibilities- Manage relationships with external partners for Quality Assurance needs
- Liaison between external and internal stakeholders of Quality Assurance and Manufacturing Operations
- Lead, approve documents, and/or participate in change controls, CAPA, deviations, and investigations
- Lead Quality Assurance manufacturing shop floor support to achieve smooth product transfer and ongoing manufacturing
- Drive product and process changes to improve product quality
- Review and aid in the establishment and maintenance of Quality Agreements
- Proactively identify and work collaboratively to resolve problems
- Lead or participate in Quality Risk Management and Data Governance Processes
- Lead pre-approval inspection readiness activities
- Participate in activities to support regulatory agency inspections
- 8+ years' experience working directly with manufacturing in the sterile injectable pharmaceutical or medical device industries
- Bachelor-level or higher education
- Project management, organization, and execution skills
- Ability to apply technical expertise to solve problems and issues
- Experience with technology transfers and new product introduction
- Knowledge of data integrity controls in a manufacturing setting
- Familiarity with Annex 1 requirements
- Excellent interpersonal and written communication skills
- Self-motivated, flexible, and able to work in a small, fast-paced, dynamic environment
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Quality Assurance Operations Manager
2 weeks ago
Petersburg, United States Civica Full timeAbout the RoleCivica is seeking a highly skilled Quality Assurance Operations Manager to lead our sterile injectables quality assurance team. As a key member of our operations team, you will be responsible for ensuring the highest quality standards are met in our manufacturing processes.Key ResponsibilitiesProvide leadership and direction to the quality...
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Quality Assurance Operations Manager
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Quality Assurance Specialist
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Petersburg, United States Civica Rx Full timeAbout Civica RxCivica Rx is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States.Our mission is to ensure that patients have access to affordable, high-quality medications. We achieve this by developing and manufacturing essential...
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Quality Assurance Specialist
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Petersburg, United States Civica Rx Full time{"title": "Quality Assurance Engineer II", "description": "About CivicaCivica is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. Our team of healthcare and pharmaceutical industry leaders works tirelessly to ensure the consistent availability of affordable...
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