Product Release Associate II at Noven Pharmaceuticals, Inc - Miami, FL in Miami, Florida

Job Description:

The purpose of this position is the review of executed batch records, analytical results and other GMP documentation for accuracy, completeness and conformance to established documentation standards, including disposition of starting materials, in process and finished products.  This position assures that all specifications are met at each stage of manufacturing and prior to final product release to comply with FDA and cGMP regulatory requirements. The scope of support includes review of batch records and analytical results for product complaint investigations and Product Development activities, and serves on assigned internal projects as a technical/compliance resource to solve quality issues.

• Compilation, review and approval of executed manufacturing Batch Records associated to all manufacturing and packaging process, analytical results and other GMP documents for product release; assign product status to ensure quality of products manufactured at the facility.


• Perform review and release activities related to raw materials and components, including materials/products related to Product Development activities.


• Positively interacts with other departments to quickly and effectively resolve documentation issues, and ensures good documentation practices are followed in reviewed GMP documentation.


• Generate material/product status labels, and assign disposition and expiration dates in JDE ERP system.


• Generate Certificate of Compliance and prepare all required paperwork, including Partners batch record packages, for releasing and shipping of finished products.


• Maintain up to date the Product Release database for tracking receipt, review and correction of Batch Records and raw materials/components release documents; file and archive all the completed records in designated filing room.


• Assist in the review and revision of departmental Standard Operating Procedures (SOPs), forms, and other GMP documents to assure compliance to corporate policies and procedures, as well as applicable regulations and requirements.


• Assist in the preparation of data and submit monthly Product Release Quality Metrics and key performance indicators.


• Serve as a QA technical/compliance resource to assist with investigations, CAPA, and Customer complaint investigations.


• Generate Change Controls, as required to support QA operations and ensure compliance with SOPs.


• Generate Minor Trend or Investigations in TrackWise for any incident or deviation detected during the lot manufacturing process or batch record review process. 


• Process Follow Up Task in TrackWise as required to assist in the disposition of materials used during the manufacturing process


• Perform other duties and additional assignments as directed by the Director Change Management.

Competencies:

Education / Experience:

BS degree or technical equivalent / Three to five years of professional experience in pharmaceutical industry and Product Release.  PC literate with basic knowledge of application software.  Understanding of internal SOPs, FDA guidelines (CFRs), and cGMP regulations.  Experience with MES e-Batch Record system, JDE ERP system and TrackWise is a plus.

Judgment / Decision Making:

Duties are performed under general direction within a framework of established and routine guidelines; some modification and interpretation required.

Work Environment:

Air-conditioned office environment.

Physical Demands:         

Visual acuity and manual dexterity required to review documents and operate computer.