Product Release Associate
Kendall, FL US
- Title: Product Release Associate II
- Location: Miami, FL
- Industry: Pharmaceutical
- Salary: $27 and up based on experience
- Employment Type: Contract to hire
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.
- 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.
- Perform review and release activities related to raw materials and components, including materials/products related to Product Development activities.
- 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
- 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.
- 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.
- Perform other duties and additional assignments as directed by the Director Change Management.
- Duties are performed under general direction within a framework of established and routine guidelines; some modification and interpretation required.
- Visual acuity and manual dexterity required to review documents and operate computer.
Work Experience and Skills:
- 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.
- BS Degree or Technical equivalent