Quality Assurance Specialist

East Brunswick, New Jersey

Position Title:

Quality Assurance Specialist



Reports To:

Associate Director of Quality Assurance

Work Location:

East Brunswick, New Jersey

Position Summary:

The Quality Assurance Specialist 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 SOP’s, Quality Agreements and SDEA’s

• 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

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

• Assist with investigations as needed.  Write and review investigation reports.

Position Requirements:



Bachelor’s degree in life sciences from an accredited college or university.



• A minimum of five (5) years of cGMP quality assurance experience in 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 Power Point

• 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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