Quality Assurance Associate

The Quality Assurance Contract team member will primarily support Batch Record Review and Product Disposition. Position may additionally support Quality System Processes, Document Change Management, GMP training program, and Product Complaint processing for a virtual pharmaceutical company environment. The position will also track quality compliance issues and support Annual Product Quality Report.

RESPONSIBILITIES:

· Review drug product manufacturing and packaging batch records and perform product disposition. Interact and resolve quality and documentation issues with the contract manufacturing organizations (CMO). Support in review and approval of CMO documents like batch records, validation protocols, and specification.

· Maintain GMP training program curriculum and update training records. Provide classroom GMP training. Provide management review metrics for training program compliance.

· Assist in coordinating, executing, and implementing processes for Quality Systems including but not limited to change management, deviation investigations, quality investigations, corrective and preventive action, and training.

· Support the Product Complaint program by conducting timely documented review and assessment of complaints; ensure timely internal review of assessment by internal stakeholder departments

· Perform Document Change Management tasks including document creation, revision, approval, distribution, obsolescence, and retention and archival; may include proofread, format, and edit new or revised documents such as SOPs, Specifications, and Labeling. Ensure periodic review of SOPs occurs as required.

REQUIREMENTS:

· Requires BA/BS degree and minimum 5 years of pharmaceutical and/or biotechnology experience in QA for above core responsibilities along with additional experience in Operations, Validation, or Document Management areas preferred.

· Experience in authoring investigation and deviation reports.

· Experience in Quality Management System (QMS) and Document Change Management (EDMS) systems or similar systems in an FDA regulated environment required.

· Ability to multi-task and adjust priorities in a fast-paced dynamic environment.

· Excellent communication skills: customer service oriented with the ability to interact well with internal customers.

· Experience with administration and maintenance of Learning Management Systems (LMS) like ComplianceWire preferred.

• Advanced MS Office and Adobe Acrobat skills in addition to strong English writing skills.
• Ability to sit at a computer, keyboard, and mouse for extended periods of time.
  

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