Quality Assurance Manager
- Expired: over a month ago. Applications are no longer accepted.
Ensures that company products meet defined quality standards through supervision of product auditing and product release groups. The QA Manager oversees review and approval of SOP's, deviation investigations, CAPA management, stability, validation, and APR's.
- Bachelor’s degree in a scientific discipline or closely aligned field.
- Minimum of six years’ experience Quality or Operations and 2 years of supervisory experience.
- Oral Product/Sterile Product Experience Preferred
- Maintains auditing and release procedures which ensure products released for shipment meet company, customer, and FDA standards.
- Responsible for oversight of review and approval of Master Manufacturing Documents, SOPs, Equipment Set-Up Instructions, and validation documents.
- Provides risk assessment over significant Quality events.
- Works with operations, laboratory, engineering, and maintenance managers and staff to develop, evaluate and implement action plans which maintain or improve product and process quality.
- Demonstrated competency in leading and guiding strategic initiatives or continuous improvement projects.
- Manage all aspects of preparation for and hosting of regulatory and customer audits. Ensure appropriate CAPAs are generated from audit findings.
- Thorough understanding of interpretation and application of cGMPs and requirements in an FDA regulated industry.
- Complete understanding of SAP Quality systems.
- Excellent oral and written communication skills and good interpersonal and relational skills.
- Thorough understanding of Quality systems and the demonstrated ability to enhance or create systems for sustainable compliance
The Bachrach Group
AddressNew York, NY
TechnologyView all jobs at The Bachrach Group