Quality Technician
TPR - Quality
- Caguas, PR
- Permanente
- Tiempo completo
Support implementation of corrective and/or preventive actions that address non-conformances root causes derived from investigations.
The Quality Technician will comply with one of the assigned roles listed below:Quality Engineering
- Notify any product or process non-conformance and escalate as appropriate.
- Execution of Quality Related Validations
- Monitoring Non-Conformance
- Performance of investigations
- Conducts and assist investigations of product issues and the gathering of information during investigations to address the nonconformance root cause analysis.
- Assist in the preparation of reports for defects trend analysis, process monitoring data (SPC) and quality summaries.
- Prepare and Execute Quality related validations (IQ, OQ, PQ, PPQ, IMV, TMV, etc.).
- Coordinates and perform applicable testing. Review and approves, as required, routine test results. Executes investigations on out of specification test results.
- Support implementation of corrective and/or preventive actions that address non-conformances root causes derived from investigations.
- Provide support as required for FDA and ISO audits.
- Execution of quality related validations
- Monitoring Non-Conformance
- Performance of investigations
- Conduct and assist Internal Audits to the QS based on applicable regulatory agency requirements
- Gathering all required information to be deployed to the organization as part of the Quality/Compliance Metrics to be presented monthly or as required.
- Follow-up response to required, Corrective, and Preventive Actions to assure they are being followed in the manufacturing areas.
- Perform the review of necessary documentation and testing to ensure that manufacturing lots meet specifications and requirements for final distribution.
- Organize product release schedule to meet or exceed departmental performance standards and track against key business performance indicators.
- Coordinate the daily review of the release schedule with Planning, Operations, Quality Control, Quality Assurance and Distribution.
- Communicate effectively and coordinates tasks with Quality Control, Operations, Quality Assurance and Distribution to ensure timely release finished product.
- Monitor the completion of documents required for batch disposition.
- Review, track and coordinate the disposition of finished product including products with performance issues.
- Responsible for researching, investigating, and documenting any issue delaying the product disposition with appropriate departments to ensure resolution of issues.
- Monitor timely receipt and review of operations and laboratory records for product release.
- Perform data entry in MES, SAP systems as required.
- Prepare product certificates as required.
- Support DHR review as needed to support NCR’s, Complaints, CAPA’s or Audit Findings.
- Support Document Control, Change Control and Training area as required.
- Handling the request of Certificates of Conformance/Quality related to products manufactured and/or shipped from Terumo Puerto Rico LLC (TPR).
- Train the manufacturing Operators and Functional Areas in applicable procedures (Manufacturing Procedures, Work Instructions etc.).
- Responsible of assuring training compliance and definition of training need of all operational personnel with the assistance of area supervisors.
- Perform Training Audits.
- Schedule and coordinate New Hire training.
- Coordinate and support all the training and cross training plan with a supervisor assuring each employee complies with the training goals.
- Conduct training certification programs with applicable procedures, following the certification checklist and test to assure the compliance of manufacturing process.
- Assist owners with providing refreshers/awareness when applicable.
- Report training failures and successes.
- Send out Periodic Review for Training Matrix/Jobs.
- Support product transfer activities.
- Generate training documentation of employees in compliance with regulatory training requirements.
- Manage the annual activity of Training Records to Document Retention. Ensure the compliance of the Quality Records.
- Ensure compliance with all TPR procedures including all applicable regulatory agency requirements.
- Basic knowledge in CAPA (i.e., investigations), validations (IQ, OQ, PQ) and statistical techniques (Minitab).
- Proficiency level knowledge of Windows based PC and application software such as MS Office (Word, Excel (Pivot/Graphs), and Power Point), is required.
- Knowledge in Visio, and Project is preferred
- Knowledge in process monitoring tools (SPC) is preferred.
- Excellent communication skills, verbal and written.
- Must have quality mindset.
- Experience in Documentation Systems.
- Must have good verbal and written communication in English and Spanish.
- Excellent Writing and Technical Skills
- Knowledge of QSR and ISO.
- Auditing and Report writing skills is preferred.
- Must be detailed oriented, self-motivated, and able to handle multiple tasks.
- This is an onsite role. Maximum remote work: 0%
- Ability to effectively work with others is highly important.
- Associates Degree in Science or Technical Degree. Bachelor’s degree in science is preferred.
- Experience in pharmaceutical or medical devices is required.
- Leadership experience in a manufacturing environment is preferred.
- Minimum of (3) three years of experience in regulated industry preferably with Auditor experience for Compliance Role.
- Knowledge of QSR and ISO standards.
- Knowledge and experience with Statistical Techniques and software.
- Quality related certification is preferred.