Final Release Coordinator
Coordinate the QA activities to be performed during the review of batch records and the release of finished product. Perform the audit process of the Certificate of Irradiation, Certificate of Release preparation and KPI's report. Also, provide status of release performance and events that avoid the release of the lots.
The Final release Coordinator will coordinate the QA activities to be performed during the review of batch records and the release of finished product. Perform the audit process of the Certificate of Irradiation, Certificate of Release preparation and KPI's report. Also, provide status of release performance and events that avoid the release of the lots.
Main Responsibilities & Tasks:
- Prepare strategy to determine daily tasks to complete the priorities for sterilization process and release the finished goods to customer.
- Provides support to generate/close CAPA and Non conformances.
- Investigate non conformance and CAPA's related to discrepancies on Final Release area.
- Perform changes to procedures as part of the improvement process of the area.
- Monitor the documentation and release audit process for the finished goods. Two QA Final Release Auditors will perform the following duties as needed:
- Performs the Batch Record audit after the manufacturing process according to applicable procedures.
- Approve the Batch Record and release the finished goods according to applicable procedures.
- Provides support to others areas regarding the lots flow after manufacturing process for sterilization process and release the finished goods.
- Maintains communication with production supervisors in order to communicate the findings after the auditing process.
- Ensure audit process controls are adequate and properly implemented.
- Communicate relevant quality issues to Manufacturing and QA Management.
- Maintain lot tracking system for FMT Batch Record.
- Monitoring of process Aging Report and provide follow up using Packaging List. Provide status of lots audited and released in a daily basis.
- Performs other duties required by the FMT Supervisors.
Qualifications & Skills:
Ability to read and comprehend instructions in English and Spanish, emails. correspondence and memos.
Ability to provide status in English language.Ability to read and interpret documents such as safety rules, operating and maintenance instructions, procedure manuals and drawings.
Ability to effectively present information in one-on-one and small group situations to customers, clients and other employees in the organization.
Ability to prepare status reports and KPI's for the area. Proficiency in use of Excel, Microsoft Word, Power Point and Basic knowledge of Statistical Analysis.
Education / Experience and Skills:
At least five years of experience in the Pharmaceutical / Medical Devices industry related to Quality Assurance; or equivalent combination of education and experience
Ability to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Bachelor Degree in Science or related.
Driving our future growth requires talented people. Sartorius is a dynamic organization suited to people who want to showcase skills, be recognized for expertise and thrive in a vibrant and innovative environment.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex or national origin. We are also an equal opportunity employer of individuals with disabilities and protected veterans.
Please view equal employment opportunity posters provided by OFCCP here
We look for employees who would like to grow with us and move the innovative life sciences sector forward. In the process, we focus on agile project work, mutual support within teams and working as equals. Sartorius thrives as a company with people who give their very best every day and who are eager to develop personally and professionally.
- Reference Number R10434
- Employment Mode Full time
- Position Regular
- Functional Area Quality
- Location Yauco (Puerto Rico)