Job Summary

Provides technical support to Quality System operations contributing to the development of any process/tools changes to improve overall quality related to the role

Job Details/Responsibilities

Ensure compliance with all TPR procedures and all applicable regulatory agency requirements.
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.

Compliance

• 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.

Job Responsibilities (continued)

Product Release

• 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).

Training

• 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.

Other duties as assigned.

Working Conditions/Physical Requirements

Knowledge, Skills and Abilities (KSA)

• 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.

Qualifications/ Background Experiences

• 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.