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 ensures 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.

Responsibilities

• Compilation, review, and approval of executed manufacturing Batch Records documents associated to all manufacturing and packaging process ensuring that these documents comply with the quality standards established and assign product status in JDE ERP system to ensure quality of products manufactured at the facility.
• Verifythat the analytical results approved by the laboratory are within specifications before releasing the Intermediate, Finished products. and other GMP documents.
• Perform review and release activities related to raw materials and components documentation, 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 by completing Batch Records Task and Lab Tasks in TrackWise System.
• 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.

Qualifications

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 computers.