Manager, Quality Assurance

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Position Title:	Manager, QA	Department:	Quality
Reports To:	Associate Director of Quality Assurance	Work Location:	East Brunswick, NJ

Position Summary:

The Quality Assurance Manager promotes, develops, and oversees compliance of the company quality system. Effectively assuring compliance of customer requirements by managing quality policies, standards, procedures, programs, and practices while driving and facilitating continuous improvement.

Essential Duties & Responsibilities:

• Maintain and prepare local Standard Operating Procedures (SOPs) and associated forms, Internal Document Change Controls, Master Finished Product Specifications, MSDS, and SDS Documents

• Maintain Document Management System (DMS) – create and update SOPs, Quality Agreements and SDEAs

• Maintain Quality Agreements and Safety Data Exchange Agreements

• Responsible for organizing and archiving cGMP documents in house

• Compile and report monthly metrics for Quality Assurance

• Maintain training matrix for all active positions

• Perform audits, both internal and external. Maintain audit schedule for domestic partners

• Review Certificates of Analysis and any applicable release documentation, e.g. Certificates of Compliance, Certificates of Conformance, Temperature Data Logger, etc.

• Review Manufacturing/Packaging Batch Records for Rising-ANDA products.

• Perform product disposition/ initiate activities related to product quarantine, release, reject, and destruction.

• Perform administrative tasks related to product release/reject in SAP system

• Working knowledge of GMPs, Guidance Documents, and Quality Systems (ex.OOS, Investigations & Deviations) and assisting in drafting up of Investigations on a need basis.

• Know how on regulatory submission requirements (CMC & Different Modules) and knowledge for review of associated modules for an ANDA submission

• Experience on the submission of Field Alert Reports would be a plus

• Experience and Know How on review of Pharmacovigilance Product Complaints and Compliant closeout

• Train Rising employees on local SOPs and associated forms as needed

• Keep updated tracking logs of Quality Agreements, External Vendor Audits, and any tracking logs associated with reviews and approvals within Quality Assurance.

Position Requirements:
Education:
Required:	Bachelor’s degree in life sciences from an accredited college or university.
Experience:
Required:	• A minimum of five (5) years of cGMP quality assurance experience in the biotechnology, pharmaceutical, or medical device industry. • Experience with review and disposition/product release of manufacturing and packaging batch records. • Working knowledge writing and following SOPs, document management/control system processes
Specialized Training or Technical Knowledge Licenses, Certifications Needed:
• Working knowledge of MS Word, Excel, Outlook, and PowerPoint
• Working knowledge of Adobe Acrobat

Functional Knowledge:
• Excellent conceptualizing, analytical and problem-solving skills

Job-Specific Competencies:

• Effective written and oral communication skills

• Strong organizational, planning, and communication skills.

• Demonstrates exceptional time management skills.

• Using logic and reasoning to identify solutions to problems.

• Ability to multi-task, set priorities and meet strict deadlines.

• Ability to lead, motivate, coach, and teach others

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Manager, Quality Assurance

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