Quality Assurance Manager
Location : Ramsey NJ US 07446
Job Type : Direct
Reference Code : 20309-AB1
Compensation : 125000.00 - 145000.00 USD/YEAR
Start Date : 09/16/2020
Hours : Full Time
Required Years of Experience : 10
Required Education : BS Biology or Chemistry
Travel : No
Relocation : No
Job Industry : Pharmaceutical
Job Description :
- Permanent position for a Quality Assurance Manager to mentor, train, develop and manage QA Associates supporting manufacturing processes ensuring safe release of products.
- Responsible for conducting Quality Assurance activities to support Quality Systems and client procedures including but document management, issuance, review and approval of batch records, QC data, SOPs, material releases and final product releases.
- Assist Quality Director with department needs.
- Implement ongoing quality improvement processes working with interdepartmental teams.
- Develop and manage quality assurance metrics for performance improvement of all teams.
- Anticipate program release problems and take corrective action, escalating as needed, to resolve and achieve commitments.
- Collaborate with other departments to develop project schedules and delegate resources to manage QA projects including software deployment, customer integration, and professional services validation.
- Ensure and promote compliance with knowledge of applicable CGMP and GTP regulations and company and client SOPs.
- Establish and maintain policy for documentation and perform internal documentation audits.
- Author and review relevant SOPs, validation and other documents.
- Issue, review and approve QC certificates, closure of Batch Records, documentation, and deviation reports.
- Control Master Batch Records, distribution and label verification.
- Ensure materials management nonconformance disposition and release activity.
- Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies.
- Coordinate and monitor the corrective action process including investigation, root cause analysis, and action plan.
- Host client audits, provide on time responses to audits, and ensure completion of corrective actions needed.
Required Qualifications :
- BS Biology or Chemistry
- Minimum 10 years of pharmaceutical or biologics industry experience.
- Must have at least 3 years of managerial level experience.
- Knowledge of flow cytometry.
- Understanding of current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs).
- Working knowledge of routine laboratory operations, equipment and systems, production processes, validation, etc.
- Sound knowledge of aseptic processing and supporting technologies.
- Strong collaborative and influencing skills to work well in a cross-functional.
- Skilled in exercising judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
- Occasional travel may be required.
Contact: Allan Berman
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